MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS; EXTRACTOR

Catalog Number 309.521

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the device was reported as broken.There was no further information.This report is for one (1) conical extraction screw for 3.5mm screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the received extraction screw shows that the first few mm (millimeter) of the threaded tip section has broken off.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.The received condition of the device is concordant with the complaint description and the complaint condition is confirmed.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.Based on the provided information we are not able to determine the exact cause of this complaint.We only can assume that exceeding applied mechanical overload during the loosening of a blocked screw caused the breakage of the threads.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.Please take notice in surgical technique guide: during insertion ensure that enough axial pressure is exerted and retain the axis.Only use sharp-edged extraction screws (recommendation: one extraction).Do not use extraction screws with power tools.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 309.521, lot: 2327241, manufacturing site: bettlach, release to warehouse date: 12.Feb.2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9491429
• MDR Text Key: 194956996
• Report Number: 8030965-2019-71225
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819204409
• UDI-Public: (01)07611819204409
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 309.521
• Device Lot Number: 2327241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/30/2020
• Patient Sequence Number: 1