MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE TIB GDE/RACHET *EA; BONENAIL GUIDEWIRE

Model Number	219301
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the moveable screw on the restore tib gde/rachet, ±10% device was not moving.There were no adverse patient consequences reported.No additional information provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that during an unknown procedure the moveable screw of the restore tibial guide/ratchet, ±10% it´s not moving.The complaint device was received and evaluated.Upon visual inspection, it could be observed that the device has marks of use as usual on these type of reusable devices.Upon reviewing the screw, it was confirmed that the adjustable screw cannot be moved due to its jammed.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection performed, this complaint can be confirmed.The root cause for the reported issue can be attributed to the constant and hard use of the device.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to jamming moving parts.As per ifu 109284: end of useful instrument life is generally determined by wear or damage from handling or surgical use.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 anterior cruciate ligament autograft procedure on (b)(6) 2021, it was observed that the moveable screw on the restore tib gde/rachet, ±10% device was not moving.The procedure was completed with the same device.There were no adverse patient consequences reported.No additional information provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11801021
• Report Number: 1221934-2021-01494
• Device Sequence Number: 11018204
• Product Code: FZX
• UDI-Device Identifier: 10886705005567
• UDI-Public: 10886705005567
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/27/2021

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: 219301
• Device Catalogue Number: 219301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 06/08/2021; 06/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/25/2021; 06/09/2021; 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1