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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. 4.5MM OSTEOFAB SUTURE ANCHOR; BONE ANCHORS, SUTURE ANCHORS
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OXFORD PERFORMANCE MATERIALS, INC. 4.5MM OSTEOFAB SUTURE ANCHOR; BONE ANCHORS, SUTURE ANCHORS Back to Search Results
Model Number SA002-45
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/22/2021
Type of Reportable Event Malfunction
Event or Problem Description
Suture anchor fractured when surgeon attempted to insert the anchor into the patient's bone.All device fragments were retrieved from the surgical site and there was no report of patient injury.Procedure was completed with additional units of the device.
 
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Brand Name
4.5MM 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 Key11504765
Report Number3009582362-2021-00003
Device Sequence Number14317649
Product Code MBI
UDI-Device Identifier00850004435045
UDI-Public(01)00850004435045(10)207215(17)241210
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K190915
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/17/2021
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 Date12/10/2024
Device Model NumberSA002-45
Device Lot Number207215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2021
Initial Report FDA Received Date03/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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