MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE

Model Number	03.110.022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The stardrive screwdriver shaft t8 for ratcheting handle (p/n: 03.110.022, lot # h867445) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was twisted and worn.The twisted/worn condition of the distal tip is consistent as an end of life indicator for the device.No other issues were identified during an inspection.The received condition is not consistent with the complaint condition thus the overall complaint was not confirmed.After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A cursory inspection of the complaint file for the device that was found damaged does not point to a manufacturing issue.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 on (b)(6) 2020, the tip of stardrive screwdriver shaft for ratcheting handle was broken off.The issue was noticed upon inspection.There was no patient involvement.This report is for one (1) stardrive screwdriver shaft t8 for ratcheting handle 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.H3, h4, h6: the stardrive screwdriver shaft t8 for ratcheting handle (p/n: 03.110.022, lot # h867445) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was twisted and worn.The twisted/worn condition of the distal tip is consistent as an end of life indicator for the device.The lot number was identified to be etched incorrectly.The received condition is not consistent with the complaint condition thus the overall complaint was not confirmed.Investigation conclusion: it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.This complaint is not confirmed.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot manufacturing location: supplier - (b)(4), packaged and released by: monument.Manufacturing date: 18-sep-2018.Part number: 03.110m022, stardrive screwdriver shaft t8 for ratcheting handle.Lot number: h867445 (non-sterile).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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: STARDRIVE SCREWDRIVER SHAFT T8 FOR RATCHETING HANDLE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9823498
• Report Number: 2939274-2020-01239
• Device Sequence Number: 19600131
• Product Code: HXX
• UDI-Device Identifier: 10886982071934
• UDI-Public: (01)10886982071934
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 03.110.022
• Device Catalogue Number: 03.110.022
• Device Lot Number: H867445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1