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

Model Number 72202273

Device Problems Break (1069); Component Falling (1105); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6949857
• MDR Text Key: 89461668
• Report Number: 1219602-2017-01300
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010622082
• UDI-Public: (01)03596010622082(17)220420(10)50660023
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 100