MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-31 for AWL F/PFNA-II 03.023.003 manufactured by Synthes Bettlach.
[58821977]
Device used for treatment, not diagnosis. Device is not distributed in the united states, but is similar to device marketed in the usa device is an instrument and is not implanted/explanted. (b)(6). Subject device has been received and a device history records was conducted. The report indicates the: dhr review for part. : 03. 023. 003 / 2751708. Manufacturing location: (b)(4). Manufacturing date: 15 july 2011. 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. An investigation summary was performed. The investigation of the complaint articles has shown that: as received condition received part: 1 x article 03. 023. 003 / awl f/pfna-ii / lot 2751708: the laser welded seam between the shaft and the handle was found broken. Furthermore we found strong hammering blows on the handle's surface. The cutting edges are blunt. Our microscopic observation shows remaining laser welds on both involved components showing that the weld joint was correct at the time of manufacturing. In particularly we want to bring up the heavy hammering marks on the handle, which are a clearly indication of an excessive force influence on the device. These repeatedly hammer blows have probably damaged the stability of the laser weld-seam which finally led into rupture of the welding joint. The actual surgical technique guide recommends how the awl should be used. There is no indication that a hammer or such a similar instrument can or must be used in combination with the awl. The article 03. 023. 003 with lot no 2751708 was manufactured in a quantity of 50 pieces on july 2011. All dimensions relevant for the function of the product were measured, and fulfil the specifications. The measurable dimensions of the awl were as far as possible checked and found to be in compliance with the technical drawings. We are not aware of any quality problems or failures caused by a faulty product on the article. Unfortunately we have no information in the complaint description about any event neither if a patient was involved in this case, which makes it impossible to determine how the device should had malfunctioned. Also we are not aware of any other complaint for this article- and lot number combination. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances. 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
[58821978]
Device report from synthes on an event in (b)(6) as follows: it was reported that the product was returned because the handle is unsoldered. The handle came off the stem without breakage. During chu investigation was detected that the laser weldseam was found broken. This complaint involves 1 part. This report is 1 of 1 for: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2016-10437 |
| MDR Report Key | 6066940 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-26 |
| Date Mfgr Received | 2016-10-26 |
| Device Manufacturer Date | 2011-07-15 |
| Date Added to Maude | 2016-10-31 |
| 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 | MARK VORNHEDER |
| 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 | AWL F/PFNA-II |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-10-31 |
| Returned To Mfg | 2016-09-06 |
| Catalog Number | 03.023.003 |
| Lot Number | 2751708 |
| ID Number | (01)07611819926622(10)2751708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |