MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE

Model Number	314.13
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: a product investigation was conducted.Visual inspection: the large hexagonal screwdriver with t-handle (p/n: 314.130, lot number: 2075657) was received at us cq.Visual inspection of the complaint device showed the distal tip was twisted.The condition of the device is consistent as an end of life indicator for the device.No other issues were identified during inspection.The received condition is consistent with the complaint condition thus the complaint is confirmed.Investigation 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.A device history record (dhr) review was conducted: part # 314.13 synthes lot # 4769284 supplier lot # 2075675 manufactured: april 2004 due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.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, upon inspecting some instruments in the sterile processing, it was noticed that two (2) screwdrivers were damaged.There was no known patient involvement.During manufacturer's investigation of the returned device on (b)(6) 2021 it was identified that the distal tip of the screwdriver was twisted.This report is for one (1) large hexagonal screwdriver with t-handle this is report 2 of 2 for complaint (b)(4).

• Brand Name: LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12054218
• Report Number: 2939274-2021-03189
• Device Sequence Number: 4421801
• Product Code: HXX
• UDI-Device Identifier: 10886982188571
• UDI-Public: (01)10886982188571
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/04/2021

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: 314.13
• Device Catalogue Number: 314.13
• Device Lot Number: 2075675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1