MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR PFNA BLADE; EXTRACTOR

Catalog Number	356.825
Medical Device Problem Codes	Mechanical Problem (1384); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part: 356.825, lot: 2107022, manufacturing site: (b)(4), release to warehouse date: 17.Aug.2004, ncr/mrr/wo was generated during production.This non-conformance is not relevant to the complaint condition since the parts were reworked and reinspected before released to warehouse.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the blade is completely jammed on the extraction screw as complained.Otherwise the extraction screw is visually in a good condition, there a some slight wear marks at the hexagon and the shaft visible.Furthermore the blade is badly damaged at the shaft.Functional test: a function test is not possible as the blade cannot be removed from the extraction screw.Dimensional inspection: the relevant dimensions cannot be verified as a removal of the blade is not possible.However, as it was possible to insert the extraction screw into the blade as required a dimensional issue can be excluded.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the complaint is confirmed as the blade is jammed on the extraction screw as complained.Based on the provided information it is not possible to determine the exact cause of this occurrence.We can only assume that a mechanical overload situation during procedure has most likely caused this malfunction.In the current condition a removal is not possible as the removal force cannot be applied onto the sleeve anymore.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, an extraction screw for proximal femoral nail antirotation (pfna) blade was defective.It was unknown where the issue occurred.Surgical procedure and patient involvement were unknown.Concomitant device reported: unknown pfna blade (part# unknown, lot# unknown, quantity 1).This report is for one (1) extraction screw for pfna blade.This is report 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREW FOR PFNA BLADE
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8474506
• Report Number: 8030965-2019-62431
• Device Sequence Number: 19201104
• Product Code: HWB
• UDI-Device Identifier: 07611819291324
• UDI-Public: (01)07611819291324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 356.825
• Device Lot Number: 2107022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1