MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201774
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during acl procedure, inside the patient, the biosure ha 7mm x 30mm was broken.All broken pieces were removed from the patient with tweezers.The procedure was finished with a smith and nephew backup device.Surgical delay less than or equal to 30 minutes.Patient injuries were not reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a broken screw with debris.An analysis of the customer provided image found part of the device in packaging for part number 72201778 lot 50823748.Based on the condition of the product material found during visual inspection it was determined that additional material testing was not required.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the raw material, found that the storage protocols, material specifications, and material tests were appropriately documented.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or torque, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE HA 7MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12136758
• Report Number: 1643264-2021-02188
• Device Sequence Number: 14450293
• Product Code: HWC
• UDI-Device Identifier: 03596010611703
• UDI-Public: 03596010611703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2024
• Device Model Number: 72201774
• Device Catalogue Number: 72201774
• Device Lot Number: 50811737
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 56