MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG; SCREWDRIVER

Catalog Number	03.632.074
Medical Device Problem Codes	Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the screwdriver shaft tip had sheared in the head of the screw on pedicle screw insertion.No loose metal tip fragments were found in the surgical site.Unable to visualize screw head to confirm metal tip pieces were lodged into the recess of the screw head.The surgeon discussed options for screw removal but was content to continue with procedure.The rod and set screws were secured unimpeded by any possible metal fragments.Concomitant device reported: devices reported: unknown screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) t-handle t25 stardrive shaft f/ matrix-long.This is report 1 of 1 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.Initial reporter is a synthes employee.Part: 03.632.074, synthes lot: 6999714, supplier lot: na, release to warehouse date: january 24, 2013, manufactured by synthes monument.No nonconformance reports (ncrs) were generated during production.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: the scrdriver t25 long w/t-handle f/matrix was received at us customer quality (cq).Upon visual inspection, the driving threads are twisted.There is no evidence of breakage or fragments being formed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as there are no signs of fragments or breakage.However, the driving threads are twisted.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9638644
• Report Number: 8030965-2020-00690
• Device Sequence Number: 16870917
• Product Code: HXX
• UDI-Device Identifier: 07611819377301
• UDI-Public: (01)07611819377301
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/07/2020

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: 03.632.074
• Device Lot Number: 6999714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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 - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention