MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. 5.5MM 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	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported quantity 2 of size 5.5mm anchors broke during surgery: one broke during insertion and one broke when surgeon attempted to back it out dur to a broken suture.Device fragments were retrieved and there is no reported injury to the patient.Procedure was completed with additional units of the device.
Event or Problem Description
Sales rep reported qty 2 of size 5.5mm anchors broke when surgeon attempted to insert them off-axis.
Additional Manufacturer Narrative
B5: corrected event description.

• Brand Name: 5.5MM 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
• MDR Report Key: 11924602
• Report Number: 3009582362-2021-00004
• Device Sequence Number: 14299966
• Product Code: MBI
• UDI-Device Identifier: 00850004435052
• UDI-Public: (01)00850004435052(10)207035(17)241113
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 11/13/2024
• Device Model Number: SA002-55
• Device Lot Number: 207035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1