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 Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation conducted to date, it was concluded that the addition of bmac and prp to the knee joint at the end of the procedure diluted the bear implant, and it may have prematurely washed out of the joint.The bear implant ifu indicated that the knee joint should be thoroughly dry to ensure that no other liquids dilute the bear implant hydrated with the whole blood.
Event or Problem Description
The bear patient's mom emailed miach indicating that the bear surgery did not treat/fix her daughter's acl.Her daughter had an 9 mo mri and the acl looked torn.(b)(6) called the patient's mom on (b)(6) 2024 based on the email she had sent miach when the mom notified that she thinks the acl was not regrown with the bear implant.She said the daughter did not have an injury, just a twist to her knee then she started feeling that it was unstable.(b)(6) also spoke with the dr.On (b)(6) 2024 to understand if there was anything out of the ordinary during the surgery.Dr.Indicated the patient was slow moving during the initial part of rehab and the only thing during surgery that was out of the ordinary was that he added bmac and prp to the knee at the end of the surgery because the patient also had a meniscus tear that he treated.

• 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: 22965619
• Report Number: 3020652-2025-00022
• Device Sequence Number: 15737668
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: (01)00860002987804(17)280825(10)7009360
• 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: 7009360
• 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