MAUDE Adverse Event Report: MIACH ORTHOPAEDICS BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT; Resorbable implant for anterior cruciate ligament (ACL) repair

Catalog Number	1000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A bear implant from lot: 7009361 came out of the packaging looking and feeling different.According to the dr.The implant was very soff compared to previous devices and she was able to squeeze it.She has done almost 30 cases so she elected to discard the device and use another.The implant was thrown in the trash and is not available for evaluation.The case was completed successfully with second implant.Patient is doing well.
Additional Manufacturer Narrative
The case was completed successfully with second implant.Patient is doing well.

• Brand Name: BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
• Common Device Name: Resorbable implant for anterior cruciate ligament (ACL) repair
• Manufacturer (Section D): MIACH ORTHOPAEDICS; 69 milk street; suite 100; westborough MA 01851
• Manufacturer (Section G): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: gregory devenne ; 69 milk street; suite 100; westborough, MA 01851
• MDR Report Key: 22965580
• Report Number: 3020652-2025-00020
• Device Sequence Number: 18419320
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: (01)00860002987804(17)281025(10)7009361
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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
• Device Expiration Date: 10/28/2025
• Device Catalogue Number: 1000
• Device Lot Number: 7009361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown