MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FEMAIMER OFFSET 7MM *EA; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Model Number	219357
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the inner wire of the restore femoral aimer 7 mm offset got stuck into the device.No visible damage was found.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.
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 by the sales rep via phone that during an acl procedure the inner wire of the restore femoral aimer 7 mm offset got stuck into the device.The complaint device was received and evaluated.Visual observation reveals the wire was not stuck into the device.In addition, the laser markings of the shaft and the handle are slightly faded and the device appears worn.Besides, tissue debris was not observed in any section of the device.The complaint cannot be confirmed.At this time, we cannot discern a root cause for the reported failure mode.A manufacturing record evaluation was performed for the finished device [0086] number, and no non-conformances were identified.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Common Device Name: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10445792
• Report Number: 1221934-2020-02294
• Device Sequence Number: 4092382
• Product Code: LXH
• UDI-Device Identifier: 10886705005970
• UDI-Public: 10886705005970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 219357
• Device Catalogue Number: 219357
• Device Lot Number: 0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1