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 2016-03-01 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[39425958]
(b)(6). Complainant part is expected to be returned for mfr review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review - manufacturing location: (b)(4). Manufacturing date: 08. June 2010. No anomalies were detected during device history record review. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[39425959]
It was reported that while performing a planned open reduction internal fixation (orif) harvesting bone graft from the iliac crest using a rotating motion, the surgeon pulled the handle back and it was discovered that the tip of the shaft had broken off inside of the trephine. The (3) pieces from the instrument were successfully removed, no fragments were generated. There was reportedly minimal surgical delay of less than one (1) minute. The surgery was completed successfully. The patient's status is successful. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[43025331]
Additional narrative: product investigation summary: one (1) shaft for trephine attachment (part 03. 111. 030 / lot 2550855) was returned for evaluation. Upon inspection of the returned instrument, it was noted that 12. 5mm of material was missing from the distal portion of the shaft. Jagged edges remained at the base of the three (3) coupling prongs. The broken prongs were not returned with the complained device. The complaint is confirmed. The shaft for trephine attachment (03. 111. 030) is a multiuse instrument that is part of the orthopedic foot instruments set. When used in conjunction with the silicone handle (03. 111. 013) and the trephine attachments, the instrument construct is intended to cut through the bone and extract bone graft. Alternatively, extraction attachments can be used to if a bone graft cannot be removed with the trephine attachments. A device history review was performed for the returned instrument? S lot number with no material record reports, non-conformance reports, or complaint-related issues identified that could have contributed to the complaint condition. The relevant product drawing was reviewed during the investigation. The returned instrument was found suitable to determine the intended device design, application, and dimensional conformity. The design is adequate for its intended use when used and maintained as recommended and did not contribute to the complaint condition. Although the definitive root cause could not be determined, it is likely that repeated use and excessive force over the last six (6) years contributed to the complaint condition. Cutting through hard bone over this period of time may have also contributed to the complaint condition. 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
[43025360]
Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. 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
| Report Number | 2520274-2016-11418 |
| MDR Report Key | 5471255 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-01 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-02-11 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2016-03-01 |
| 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 |
| 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 | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2016-03-01 |
| Returned To Mfg | 2016-03-21 |
| Catalog Number | 03.111.030 |
| Lot Number | 2550855 |
| ID Number | (01)10886982072283(10)2550855 |
| 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 | 2016-03-01 |