MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRFX ADV - LG 23MM INSERTER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	254832
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that before an anterior cruciate ligament reconstruction the large 23 mm sheath inserter was clogged.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 before an anterior cruciate ligament reconstruction the large 23 mm sheath inserter was clogged.The complaint device was received and evaluated.Visual observations confirm that the sheath inserter was found blocked.In addition, the device presented light nicks and marks of wear in the handle.The complaint can be confirmed.The possible root cause for the reported failure can be occurred during cleaning/ sterilization procedures.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:1807001, 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.

• Brand Name: INTRFX ADV - LG 23MM INSERTER
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10645587
• Report Number: 1221934-2020-02907
• Device Sequence Number: 3649220
• Product Code: LXH
• UDI-Device Identifier: 10886705026302
• UDI-Public: 10886705026302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 254832
• Device Catalogue Number: 254832
• Device Lot Number: 1807001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1