MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET CANN. SCREWDRIVER; SURGICAL SCREWDRIVER, REUSABLE

Model Number	285220
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information received, it was reported that during an unknown procedure the 2.5mm cannulated screwdriver was stripped.The device is available for evaluation.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the distal tip of the screwdriver was deformed.There were a lot of scratches observed on the returned device.Hence, the reported condition can be confirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The possible root cause for the reported condition can be that the device encountered unintended forces during its use.As per ifu, inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.Replace all dull instruments.For instruments that are provided in sets, instrument trays may be used for containment during sterilization.Place the instrument in the appropriate location within the sterilization tray.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the sales rep that during an unknown surgery on (b)(6) 2021, it was observed that the latarjet cann.Screwdriver device was stripped.During in-house engineering evaluation, it was determined that the distal tip on the device was deformed.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: LATARJET CANN. SCREWDRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12638982
• Report Number: 1221934-2021-03013
• Device Sequence Number: 3451457
• Product Code: LXH
• UDI-Device Identifier: 10886705017904
• UDI-Public: 10886705017904
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 285220
• Device Catalogue Number: 285220
• Device Lot Number: 10D2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1