MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRABRACE KIT; BIT, DRILL

Catalog Number	72205500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Osteomyelitis (4533)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates 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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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 after ankle surgery performed on (b)(6) 2025 where an ultrabrace kit was used, the patient developed a post-operative infection last week.Tunneling to the ankle joint was noted, and the bone scan was positive for septic arthritis/osteomyelitis.The patient is currently being treated, and no further complications were reported.
Event or Problem Description
It was reported that, after ankle surgery had been performed on (b)(6) 2025, the patient developed a postoperative infection a month later.Tunneling to the ankle joint was performed, and the bone scan was positive for septic arthritis/osteomyelitis.The patient is currently being treated for this condition.No further complications were reported.The ultrabrace kit (72205500, lot: 2153623) and q-fix with needles - minitape (72205695, lot: 2155555/72205695, lot: 2160476/72205695, lot: 2159200) were used during the procedure, with no device failures reported.
Additional Manufacturer Narrative
H2: additional information in b5 and h11.D4, lot no: the following are the lot numbers of concomitant devices present in surgery with no malfunction: 2155555, 2160476 and 2159200.Pn: 72205695 & ln: 2155555.Expiration date: 12-jun-2027 | manufacturing date: 12-jun-2024.Pn: 72205695 & ln: 2160476.Expiration date: 31-jul-2027 | manufacturing date: 31-jul-2024.Pn: 72205695 & ln: 2159200.Lot does not match information in our system, clarification was requested.

• Brand Name: ULTRABRACE KIT
• Common Device Name: BIT, DRILL
• 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: 21628268
• Report Number: 1219602-2025-00607
• Device Sequence Number: 15712056
• Product Code: HTW
• UDI-Device Identifier: 00885556890752
• UDI-Public: 885556890752
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K232457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72205500
• Device Lot Number: 2153623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• 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; Other
• Patient Age: 53 YR
• Patient Sex: Female