MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
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.Additional narrative: udi: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.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 sales rep that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that one of the sleeves on the rigidfix biocryl 2.7 mm btb cross pin kit device broke in half as the surgeon was inserting it.According to the report, the second sleeve and backup both went in with no problem to complete the procedure with a minimal unspecified delay.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 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 forthe initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.However the customer provided a photo which is showing the broken metal sleeve.A manufacturing record evaluation was performed for the finished device 9l56972 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo result, this complaint can be confirmed.The possible root cause for the broken condition can be attributed to procedural variables, such handling of the device or product interaction during procedure, a bad axis alignment of the drill at the moment of insertion, the bending force applied and the higher spinning speed of the drill can contribute to a jamming condition of the sleeve and the trocar leading in a sleeve breakage.As per ifu: directions for a successfully hole drilling and trocar and sleeve interaction are provided.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.

• Brand Name: RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 15954709
• Report Number: 1221934-2022-03919
• Device Sequence Number: 15078881
• Product Code: MAI
• UDI-Device Identifier: 10886705001293
• UDI-Public: 10886705001293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Expiration Date: 06/30/2025
• Device Model Number: 210815
• Device Catalogue Number: 210815
• Device Lot Number: 9L56972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown