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	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case was completed successfully with a second implant.Patient is doing well.
Event or Problem Description
The bear implant did not hydrate properly and in fact, not really at all.We hydrated the device with 15cc whole blood, then let the tourniquet down to fill up the specimen cup with another 20+ cc of blood.After about 5 minutes of waiting for the implant to hydrate, dr.Attempted to pass the device through the arthrotomy and the implant broke in half vertically.He took one of the halves and submerged it in the specimen cup of blood and it still didn't get any softer.We opened a second implant from a different lot, and it hydrated immediately so we were able to finish the procedure, but dr.Said that what was left of the first implant was still very firm inside the knee when he closed (the knee).Procedure 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: 22965575
• Report Number: 3020652-2025-00018
• Device Sequence Number: 15730686
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: (01)00860002987804(17)280825(10)7009362
• 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: 08/28/2025
• Device Catalogue Number: 1000
• Device Lot Number: 7009362
• 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