MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-02-25 for CHISEL HANDLE 399.54 manufactured by Synthes Bettlach.
[39006047]
Patient information not provided by reporter. (b)(4). Device is an instrument and is not implanted/explanted. Unknown if device is/not expected to be returned for manufacturer review/investigation. A service history evaluation/review was attempted. The investigation of the complaint articles has shown that:service history review: part no. 399. 54, lot no: unknown. No service history review can be performed because the lot number is unknown and cannot be traced. The manufacture date is unknown. The service history evaluation is unconfirmed. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the service & repair history review has been requested. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[39006048]
Service and repair department documented that a handle of chisel broke. No further information was given. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[40335399]
Device was used for treatment, not diagnosis. Lot number, serial number and udi were obtained upon receipt of the subject device. A service and repair evaluation was performed for the subject device. The customer reported the handle was broken. The repair technician reported? Handle cracked/broken? ; however, the instrument is not repairable. The cause of the issue is unknown. The subject device was forwarded to synthes customer quality for additional investigation. Service and repair record and device history record reviews have also been requested. The results of the investigations are pending completion. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[41440489]
No service history review can be performed as part number 399. 54 with lot number(s) 2090/(b)(4) is a lot/batch controlled item. The manufacture date of this item is october 28, 1999. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. Device history record not available as device is older than 15 years. According to procedure, the records have to be stored for 10 years. No patient information provided because there was no patient involvement. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[41831546]
Product investigation summary: the returned chisel handle is included in the hip preservation surgery and lcp anterior ankle arthrodesis plates sets and used for bone correction. Based on surgical need, various sizes of chisel blades are offered as attachments which can be attached to chisel handles and used to modify bone as needed. The returned chisel handle was received with signs of heavy usage over its over 15 years of use, including a cracked phenolic handle. The proximal end of the handle had clear signs of repeated impact. A device history record was not available for the returned chisel handle as the device is over 15 years old. Based on the original manufacturing documentation, the returned chisel handle was manufactured in october, 1999. The relevant drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. The complaint description stated that the handle of a chisel broke, but no further information was given. Based on the lack of sufficient information, it is not possible to determine a definitive root cause. The broken phenolic handle is made of polyamide 6/6, which is one of the most versatile engineering thermoplastics because of its excellent balance of strength, ductility, and heat resistance. Nylon 6/6 is considered an outstanding candidate for metal replacement applications. Although the handle is durable and designed to withstand the conditions it is exposed to during use and sterilizations, heavy usage over 15 years of use, along with sterilizations, most likely contributed to the complaint condition. The cumulative effect of the handle being struck while attempting to correct bone could have also played a role in the cracking of the handle. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-11291 |
| MDR Report Key | 5460161 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-04 |
| Date Mfgr Received | 2016-04-01 |
| Device Manufacturer Date | 1999-10-28 |
| Date Added to Maude | 2016-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL HANDLE |
| Generic Name | CHISEL,BONE,SURGICAL |
| Product Code | EML |
| Date Received | 2016-02-25 |
| Returned To Mfg | 2016-02-29 |
| Catalog Number | 399.54 |
| Lot Number | 4024340 |
| ID Number | (01)10886982202895(10)4024340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH PA CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-25 |