MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK, 9 X 30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202273
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that one patient was having a standard acl reconstruction using hamstring tendons secured with endobutton (femur) and biosure pk.The allograft was sized as 9mm and a 9mm hole was drilled in the tibia.After the graft was instituted a 1.2mm guidewire was inserted and the chosen 9 x 30mm biosure pk screw was inserted.It appeared not easily inserted and had no bite in the tissue.On removal of the screw it was noted that the tip had broken off.Another 9 x 30mm biosure pk screw was chosen and it was inserted without any problems.No patient injury reported.
Additional Manufacturer Narrative
During attempted insertion, the screw was not biting and with removal, the tip was found to have broken off.The tiny portion of tip was not returned.There is guide wire damage up and down the thread outer diameters.There is also rolling and compression of the outer diameters.The product reported is longer than the recommended max length for the reported procedure.No root cause related to the manufacturing of this device can be confirmed.

• Brand Name: BIOSURE PK, 9 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6949857
• Report Number: 1219602-2017-01300
• Device Sequence Number: 795798
• Product Code: MBI
• UDI-Device Identifier: 03596010622082
• UDI-Public: (01)03596010622082(17)220420(10)50660023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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: 04/20/2020
• Device Model Number: 72202273
• Device Catalogue Number: 72202273
• Device Lot Number: 50660023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 100