MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8 MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201778
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a posterior cruciate ligament reconstruction, the screw broke while implanting.Broken pieces were removed and the procedure was completed with a backup device with no significant delay or patient injury reported.
Additional Manufacturer Narrative
The reported 8x30mm biosure ha screw intended for use in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 9mm of the distal threads of the screw have broken off and were not returned for examination.The break is angular in nature.Dimensional assessment of the screw major diameter and wall thickness was performed and found to meet print specifications.An exact root cause cannot be determined with confidence, however, factors that could have contributed to the reported event include: not using a tap in hard bone applications.Choosing the improper size screw.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: BIOSURE HA 8 MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8914846
• Report Number: 1219602-2019-00993
• Device Sequence Number: 11262698
• Product Code: HWC
• UDI-Device Identifier: 03596010611741
• UDI-Public: 03596010611741
• 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): 09/09/2019

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: 07/10/2023
• Device Catalogue Number: 72201778
• Device Lot Number: 50746141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR