MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T4/66MM; SCREWDRIVERS

Catalog Number	03.114.010
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.114.010; synthes lot: 7847046; supplier lot: na; release to warehouse date: march 19, 2015; manufactured by synthes (b)(4).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.Flow: damage: visual (appearance not as expected).Visual inspection: the returned device was examined and was found to have a stripped distal tip.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.No further visual defects or deficiencies were noted.Conclusion: after a visual inspection per guidance, 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.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 during an unknown procedure on an unknown date, the stardrive screwdriver shaft t4 and stardrive screwdriver shaft t4, self-retaining are not effectively driving the screws in.Procedure outcome and patient status are unknown.Concomitant medical products: screws (part: unknown, lot: unknown, quantity: unknown).This report is for a stardrive screwdriver shaft t4/66mm.This is report 1 of 2 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8282764
• Report Number: 2939274-2019-56099
• Device Sequence Number: 1953164
• Product Code: HXX
• UDI-Device Identifier: 10886982073044
• UDI-Public: (01)10886982073044
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 03.114.010
• Device Lot Number: 7847046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1