MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

Catalog Number	03.010.150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scrdriver-hex ø3.5 combined w/stardr t25 (part #: 03.010.150 and lot #: 5669029) was received at us cq.Upon visual inspection, it was observed that the tip of the device was stripped and twisted.It was observed that there were scratches on the device but has no impact on the functionality of the device.Due to the worn condition of the tip, device functionality was compromised.The noted issues were consistent as end of life indicators for the device.No other issues were identified with the returned device.After a visual inspection per guidance provided in windchill document, 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 history lot: part # 03.010.150.Synthes lot # 5669029.Supplier lot # n/a.Release to warehouse date: 2 jan 2008.Manufacturer: (b)(4).No ncr's 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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the screwdriver tip was defective.This was discovered during an unknown procedure.Procedure was delayed by five minutes.No further information.This report is for (1) star/hexdrive screwdriver t25 3.5mm hex/self-retaining.This is report 1 of 1 for (b)(4).

• Brand Name: STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12210804
• Report Number: 2939274-2021-04209
• Device Sequence Number: 3130337
• Product Code: HXX
• UDI-Device Identifier: 07611819900806
• UDI-Public: (01)07611819900806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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 Catalogue Number: 03.010.150
• Device Lot Number: 5669029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1