MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 2.5MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	314.29
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is j&j employee.A device history record (dhr) review was conducted: part: 314.290-us.Lot: 3685362.Manufacturing site: (b)(4).Release to warehouse date: 22.March 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: the cannulated 2.5 mm hexagonal screwdriver (p/n 314.29 lot 3685362) was received showing the distal driver tip stripped, worn, and slightly twisted in the direction of resistance from insertion.No other issues were identified with the device.The stripped/worn/twisted driver tip is a potential end of life indicator for the instrument from normal wear and consistent use over the part¿s lifetime.Conclusion: 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.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, while picking up the set, the sales consultant noticed that a cannulated hexagonal screwdriver was noted to have a slightly twisted on the end making it difficult to seat into an unknown screw heads.There was no patient involvement.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) cannulated 2.5 mm hexagonal screwdriver.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CANNULATED 2.5MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8982645
• Report Number: 2939274-2019-60420
• Device Sequence Number: 3324420
• Product Code: HXX
• UDI-Device Identifier: 10886982188762
• UDI-Public: (01)10886982188762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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 Model Number: 314.29
• Device Catalogue Number: 314.29
• Device Lot Number: 3685362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1