MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG

Model Number	03.100.045
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown date, the four (4) stardrive screwdriver shafts were damaged.The stardrive shafts would not load into a standard ao quick connect chuck on the drill, several chucks and variations were tried.The issue was discovered during routine inspection.There was no patient involvement.Concomitant device reported: unknown ao quick connect (part# unknown, lot# unknown, quantity unknown).This report is for one (1) stardrive screwdriver shaft t15 250mm long.This is report 3 of 4 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: part 03.100.045, lot 5446943: release to warehouse date: april 20, 2007.Manufactured by synthes monument.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection, the screwdriver shaft had a nick at the proximal end of the device and also scratches and scuffs consistent with field usage were observed on the device.No other issues were identified with the returned device.A functional test cannot be performed as the device was returned by itself.The diameter of the shaft was measured; it measured within the specified dimensions.The relevant documents were reviewed; no design issues or discrepancies were identified.The complaint condition cannot be confirmed.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 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 T15 250MM LONG
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10739998
• Report Number: 2939274-2020-04827
• Device Sequence Number: 3141496
• Product Code: HXX
• UDI-Device Identifier: 10886982070944
• UDI-Public: 10886982070944
• Combination Product (Y/N): N
• 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): 09/30/2020

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: 03.100.045
• Device Catalogue Number: 03.100.045
• Device Lot Number: 5446943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: UNKNOWN AO QUICK CONNECT; UNKNOWN AO QUICK CONNECT