MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-9MMX30MM TPRSCR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254624
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported by the affiliate in (b)(4) that seven days after an anterior cruciate ligament reconstruction procedure on (b)(6) 2021 implanting biointrafix 7-9mmx30mm tprscr and biointrafix tbial sh lrg 30mm devices, it was observed that the patient had a fever.It was reported that the patient was treated with anti-inflammatory drug for one week then recovered.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that 7 days after an acl reconstruction with two bio-intrafix anchors, the patient had fever, and it was treated with anti-inflammatory drug for one week, the patient fully recovered.No produuct malfunctions were reported.The complaint devices remains implanted, therefore unavailable for a physical evaluation.Since the complaint devices were not returned, we cannot determine a root cause for the reported complaint.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [6l68514] 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.

• Brand Name: BIOINTRAFIX 7-9MMX30MM TPRSCR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11314991
• Report Number: 1221934-2021-00492
• Device Sequence Number: 14375674
• Product Code: HWC
• UDI-Device Identifier: 10886705013210
• UDI-Public: 10886705013210
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• 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
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 254624
• Device Catalogue Number: 254624
• Device Lot Number: 6L68514
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention