MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 11MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201788
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction surgery, the biosure screw broke when being implanted.After removal, it was replaced with a back up device but it is unknown whether another bone hole had to be drilled.The surgery was not significantly delayed.The patient was not injured.
Additional Manufacturer Narrative
One 11x25mm biosure regenesorb screw was returned for evaluation.Visual assessment of the screw could not confirm the reported breakage.The screw is intact, however the first distal thread is slightly deformed.Dimensional assessment of the screws major diameter, length and wall thickness was performed and found to meet print specifications.The clinical details were reviewed and confirmed that the patient had hard bone and that a tunnel of 11mm was utilized.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIOSURE HA 11MM X 25MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8842516
• Report Number: 1219602-2019-00895
• Device Sequence Number: 1606953
• Product Code: HWC
• UDI-Device Identifier: 03596010611840
• UDI-Public: 03596010611840
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 03/23/2022
• Device Catalogue Number: 72201788
• Device Lot Number: 50654545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1