MAUDE Adverse Event Report: SYNTHES GMBH SD SCRWDRVR SHFT/T6 50/SELF-RETAIN/HXC; SCREWDRIVER

Model Number	03.130.020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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
It was reported that on (b)(6) 2023, the t-6 screwdriver tip broke.The procedure was completed successfully with unknown surgical delay.There were no patient consequences.This complaint involves one (1) device.This report is for one (1) sd scrwdrvr shft/t6 50/self-retain/hxc.This is report 1 of 1 for 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.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the tip of sd scrwdrvr shft/t6 50/self-retain/hxc, p/n: 03.130.020, lot: 9836642, was broken.The broken fragment was not visible in the provided evidence.No other problem identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for sd scrwdrvr shft/t6 50/self-retain/hxc, p/n: 03.130.020, lot: 9836642.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 # 03.130.020.Synthes lot # 9836642.Supplier lot # n/a.Release to warehouse date:08 sep 2015.Manufactured by: synthes monument.No ncrs were generated during production.Device history review: 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.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: SD SCRWDRVR SHFT/T6 50/SELF-RETAIN/HXC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16814377
• Report Number: 8030965-2023-05260
• Device Sequence Number: 5523201
• Product Code: HXX
• UDI-Device Identifier: 10886982075208
• UDI-Public: (01)10886982075208
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 03.130.020
• Device Catalogue Number: 03.130.020
• Device Lot Number: 9836642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown