MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-8MM SHEATH TRIAL; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	254650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up medwatch will be filed as appropriate.Udi: (b)(4) incomplete.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 affiliate in australia that during an anterior cruciate ligament (acl) procedure on (b)(6) 2020, it was observed that the biointrafix 7-8mm sheath trial device broke.According to the report, the weld site of handle sheared off while malleting out of tibia.The device was removed manually and the procedure continued to be completed successfully.There were no fragments generated.There were no adverse patient consequences 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 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 an intrafix sheath dilator breakage intra-operatively.Weld site of handle sheared off whilst malleting out of tibia.The complaint device was received and evaluated.When performing the visual inspection at the tip trial, it could be identified some spots of rust on the etch marks.The t-handle is separated off from the tip trial, it could be observed that the welding that keeps both pieces together is broken.Also, some rust could be observed in the insert section of both pieces.According with the visual inspection result, this complaint can be confirmed.This failure can be attributed to fair wear and tear of the device due to the rough and repeated malleting of the device.The cause for rusting can be attributed to the sterilization process in autoclave, the device was possibly left to dry along with other metal instruments resulting in galvanic corrosion.However this cannot be conclusively determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

• Brand Name: BIOINTRAFIX 7-8MM SHEATH TRIAL
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10927747
• Report Number: 1221934-2020-03635
• Device Sequence Number: 3299705
• Product Code: LXH
• UDI-Device Identifier: 10886705013418
• UDI-Public: 10886705013418
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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: 254650
• Device Catalogue Number: 254650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 12/20/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/18/2020; 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR