MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 11 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202279
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the 2021 new zealand acl registry implant report from new zealand that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that on registry review 2021 new zealand acl registry implant report, an unknown amount of patients required a revision surgery after an acl procedure using biosure pk screw devices.It is unknown how were the events treated/resolved.Patients outcome is unknown.No further information is available.
Additional Manufacturer Narrative
Corrected data: b5, d1/d2a/d2b, d4.
Event or Problem Description
It was reported that on registry review 2021 new zealand acl registry implant report, an unknown amount of patients required a revision surgery after an acl procedure using biosure pk 11 x 25mm screw devices.It is unknown how were the events treated/resolved.Patients outcome is unknown.No further information is available.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: additional information: h6: health effect - clinical code.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states that there were no clinical factors found which would have definitively contributed to the reported event (¿an unknown amount of patients required a revision surgery after an acl procedure using biosure pk screw devices,¿).The patient impact beyond the reported events could not be determined.Should any additional clinical information be provided for this complaint will be re-evaluated.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE PK 11 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15817896
• Report Number: 1219602-2022-01761
• Device Sequence Number: 5402482
• Product Code: MBI
• UDI-Device Identifier: 03596010622143
• UDI-Public: 3596010622143
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 72202279
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 09/03/2025; 11/21/2025
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 09/23/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown