MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. OSTEOFAB SUTURE ANCHOR; BONE ANCHORS, SUTURE ANCHORS

Model Number	SA002-55
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported breaking three 5.5mm osteofab suture anchors in surgery.This was the surgeons first time using the system.

• Brand Name: OSTEOFAB SUTURE ANCHOR
• Common Device Name: BONE ANCHORS, SUTURE ANCHORS
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite road; south windsor, CT 06074 ; 8606569438
• MDR Report Key: 14341698
• Report Number: 3009582362-2022-00004
• Device Sequence Number: 20047476
• Product Code: MBI
• UDI-Device Identifier: 00850004435052
• UDI-Public: (01)00850004435052(10)210338(17)260604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2026
• Device Model Number: SA002-55
• Device Lot Number: 210338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown