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

Model Number	72202273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl surgery the biosure had a slight divet in the head, it seems to be a detached fragment but the surgeon decided to implant it anyway.The procedure was successfully completed without a significant delay using the same device.No patient injuries other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6, h10: internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.An analysis of the customer provided image revealed a small indentation at the base of the screw.Its location appeared to be consistent with that of the gate break hole.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the part drawing found that the gate vestige and gate break hole are specified and acceptable features.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: BIOSURE PK 9 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11072244
• Report Number: 1219602-2020-02176
• Device Sequence Number: 3310714
• Product Code: MBI
• UDI-Device Identifier: 03596010622082
• UDI-Public: 03596010622082
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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 Model Number: 72202273
• Device Catalogue Number: 72202273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1