MAUDE Adverse Event Report: DEPUY MITEK LLC US ACORN REAMER, 5.5MM; CANNULATED SURGICAL DRILL

Model Number	219441
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in japan that postoperatively to an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that the acorn reamer, 5.5mm device could not be detached from a competitor's chuck device.It was reported that the procedure was completed successfully with no adverse patient consequences reported nor surgical delay reported.No additional information was 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).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.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.Further, as per the manufacturer the lot number provided was incorrect which precludes conducting a dhr review or a lot specific search in the complaints handling system.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 willbe filed as appropriate.H10 additional narrative: investigation summary: upon visual inspection the device present wear use.It could be observed scratches on the device and the laser etch marks faded.Finally, no structural anomalies were found.Given that no lot number was provided and was no visible on the device, a 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 result, for the reported failure the complaint cannot be confirmed, only the acorn reamer was received and considering that the jacobs chuck device was used during procedure and is part of the issue reported we cannot discern a definitive root cause.A possible root cause is that it is a reusable device; this condition has possibly occurred after using it for many procedures.The possible root cause for the condition of the device could be related to heavily use; moreover, drop of the unit, mishandling or procedural variables that could cause the tibial ratchet pawl and spring are missing in the device.However, it cannot be conclusively affirmed.As per ifu, between uses, lubricate moving parts with a water-soluble lubricant in accordance with the manufacturer¿s instructions.Visually inspect the instrument and check for damage and wear, cutting edges should be free of nicks and have a continuous edge, jaws and teeth should align properly, moveable parts should have smooth movement without excessive play, locking mechanisms should fasten securely and close easily, long, thin instruments should be free of bending and distortion.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.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: 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.

• Brand Name: ACORN REAMER, 5.5MM
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14916828
• Report Number: 1221934-2022-02002
• Device Sequence Number: 15025296
• Product Code: LXH
• UDI-Device Identifier: 10886705006472
• UDI-Public: 10886705006472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 219441
• Device Catalogue Number: 219441
• Device Lot Number: ACORN0151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 07/26/2022; 08/08/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/27/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown