MAUDE Adverse Event Report: SYNTHES GMBH T-HANDLE BALL HEX SCREWDRIVER 8MM; SCREWDRIVERS

Model Number	03.010.517
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) 2021, it was difficult to remove the connecting screw from the tfna.It was unknown if the procedure completed successfully.There was no patient consequence reported.This complaint involves nine (9) devices.This report is for (1) t-handle ball hex screwdriver 8mm.This is report 3 of 9 or complaint (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.H10 additional narrative: d4.Expiration date and lot.D9.Date device returned to manufacturer.H4.Device manufacture date.H6 - codes updated to imdrf codes.Visual inspection: t-handle ball hex screwdriver 8mm (p/n: 03.010.517, lot #: l507310) was returned and received for analysis.No defects were observed with the returned device.Functional test: functional test with a mating device was performed.No defects were observed during functional evaluation.Dimensional inspection: dimensional inspection was not performed due to complex geometry.Can the complaint condition be replicated? no, the complaint condition cannot be replicated.Complaint confirmed: no, the complaint cannot be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (t-handle ball hex screwdriver 8mm) is not confirmed.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 history lot - part: 03.010.517.Lot: l507310.Manufacturing site: (b)(4).Supplier: n/a.Release to warehouse date: 15 sep 2017.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot 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: T-HANDLE BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12980087
• Report Number: 8030965-2021-10128
• Device Sequence Number: 4883989
• Product Code: HXX
• UDI-Device Identifier: 10886982069306
• UDI-Public: (01)10886982069306
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2021

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 Model Number: 03.010.517
• Device Catalogue Number: 03.010.517
• Device Lot Number: L507310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown