MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL; SCREWDRIVERS

Catalog Number	03.505.205
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an implant removal procedure for the midface occurred on (b)(6)j 2019 for an unknown reason.The procedure was to remove nine (9) screws.The screwdriver did not properly engage with multiple screws.Two screws were removed with the screwdriver.However, there was continued difficulty and the surgeon needed to remove seven (7) screws out of the nine by grinding those screws with a drill.The procedure was delayed by 70 minutes.Concomitant device reported: unknown powered drivers/handpieces: trauma (part# unknown, lot# unknown, quantity# 1).Unknown screws (part# unknown, lot# unknown, quantity# 2).This is report 1 of 8 for (b)(4).
Additional 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.Part: 03.505.205 synthes lot: 9936317.Supplier lot: 9936317.Manufacturing site: synthes monument.Release to warehouse date: january 12, 2016.Supplier: s.S.White medical products.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: a visual inspection was performed.The tip of the screwdriver was observed to be broken.The broken off part was also returned.Additionally, the tip section of the instrument is twisted.Dimensional inspection: due to the damages, the relevant dimension could not be measured.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.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.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Summary: a visual inspection was performed.The tip of the screwdriver was observed to be broken and the broken part was also returned.Additionally, the tip section of the instrument is twisted.This lot was manufactured in january 2016 according to the specification.Based on that and the condition of the item, a product related issue can be excluded.Unfortunately, we are not able to determine the exact cause which has led to this occurrence.However, due to the visible twisted tip section we must assume that a lot of force was applied onto the instrument which finally has led to the breakage of the tip section.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.
Additional 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.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: CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9224966
• Report Number: 8030965-2019-69544
• Device Sequence Number: 18865267
• Product Code: HXX
• UDI-Device Identifier: 07611819333864
• UDI-Public: (01)07611819333864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.505.205
• Device Lot Number: 9936317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 11/20/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/19/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention