MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202267
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer layer of the screw peeled during insertion and a replacement was required.No patient injuries or significant delay reported.Procedure was finished with the same device.There was no loss of tissue fixation, no additional bone hole required, no void left in the patient's bone.The layer that peeled off was removed from the patient with no issues.
Additional Manufacturer Narrative
The reported 8x25mm biosure ha screw intended for use in treatment, was not returned for evaluation.Clinical details provided confirmed that the 8mm screw threads peeled off during insertion into the 7mm tunnel.In using an 8 mm screw the threads likely came in contact with the hard cortical layer of bone during insertion.If the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: BIOSURE PK 8 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8438348
• Report Number: 1219602-2019-00328
• Device Sequence Number: 1103949
• Product Code: MBI
• UDI-Device Identifier: 03596010621627
• UDI-Public: 03596010621627
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 01/03/2023
• Device Catalogue Number: 72202267
• Device Lot Number: 50705711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1