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	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procedure was completed successfully with second implant.Patient is doing well.
Event or Problem Description
Implant looked a little off from the start.Couldn't differentiate porous and dense side.Both looked a little rough and there wasn't a flat straight surface visible like we normally see on the dense side.Surgeon passed two suture tape tails through the implant, both towards the middle of the implant.When we went to hydrate, we hydrated the top half of the implant and it hydrated within 20 seconds.When the surgeon began to slide it towards the knee, it completely fell off of the sutures outside of the knee.We opened a new implant and passed the cinch sutures through it and it hydrated much more normally and implanted normally.

• 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: 22964747
• Report Number: 3020652-2025-00015
• Device Sequence Number: 15741078
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: (01)00860002987804(17)280825(10)7009197
• 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: 7009197
• 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