MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER SHAFT SDDRIVE 165MM; SCREWDRIVERS

Model Number	03.113.019
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, during inspection, the following devices were set aside for complaints: the handle with quick coupling has a cracked, depth gauge needle popped off, two stardrive screwdriver shaft was warped, and one screwdriver was flattened.There was no patient involvement.This complaint involves (5) devices.This report is for (1) screwdriver shaft sddrive 165mm.This report is 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: 03.113.019-us, lot: 3343523, manufacturing site: hagendorf, release to warehouse date: march 4, 2010.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the screwdriver shaft sddrive 165mm (part #: 03.113.019, lot #: 3343523) was received at us customer quality (cq).Upon visual inspection the hexdrive tip was worn.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.

• Brand Name: SCREWDRIVER SHAFT SDDRIVE 165MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12469337
• Report Number: 2939274-2021-05420
• Device Sequence Number: 19777989
• Product Code: HXX
• UDI-Device Identifier: 10886982072856
• UDI-Public: (01)10886982072856
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 03.113.019
• Device Catalogue Number: 03.113.019
• Device Lot Number: 3343523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; HANDLE WITH QUICK COUPLING, SMALL; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE(TM) SCREWDRIVER T15; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; HANDLE WITH QUICK COUPLING, SMALL; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE(TM) SCREWDRIVER T15