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

Catalog Number	72201774
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a prosthesis implant, the biosure ha screw broke while implanted.All fragments were removed.A back-up screw was available and used in the same bone hole in order to finish the procedure.Neither significant delay nor patient injuries were stated.As for surgical preparation, the patient had an average bone quality.An autogenous graft was used.Both tunnel size and tibial driller had 7 mm.All preparation instruments were s&n products.
Additional Manufacturer Narrative
One (b)(4) biosure 7x30mm ha screw returned.The complaint stated: ¿the biosure ha screw broke while implanted.¿ dimensional inspection verified this as a 7mm product.The screw displays fractures, cracks and sharp edges.Two portions were returned.The symptoms are consistent with entanglement with another instrument or device.It is also consistent with excess torque applied as when unexpected bone density is encountered.Prep details were relayed but it was not specified which type of prep instruments were used although it was confirmed that they created a 7mm tunnel.Size is adequate for normal bone condition.

• Brand Name: BIOSURE HA 7MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8217245
• Report Number: 1219602-2019-00029
• Device Sequence Number: 19230650
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: 06/15/2022
• Device Catalogue Number: 72201774
• Device Lot Number: 50669761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR