MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S 2 UB STR BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203852
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy procedure, suture fix anchors pulled out, a new bone hole was drilled.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.
Event or Problem Description
It was reported that, during an arthroscopy procedure, the suture fix anchors pulled out.A new bone hole was drilled.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.The patient current status is good.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12375048
• Report Number: 1219602-2021-01800
• Device Sequence Number: 3938664
• Product Code: MBI
• UDI-Device Identifier: 00885554030037
• UDI-Public: 00885554030037
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2025
• Device Model Number: 72203852
• Device Catalogue Number: 72203852
• Device Lot Number: 2065058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other