MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631021
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use 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 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 during a trauma 02 intra-femoral rod (tan) procedure, and while following the instructions for use, it was identified that the hole alignment on one (1) 13 x 36 130 d tan lt lime rod was incorrect.Using the percutaneous drill guide, two attempts were made to adjust the guide anteriorly, but alignment could not be achieved.The surgeon subsequently elected to use a competitor's device, despite the tan rod and three guide wires already being opened.Additionally, during the same procedure and while drilling proximally for rod fixation, a deviation between the rod and one (1) tan/fan perc drill guide was observed.The surgeon attempted correction twice without success.When the rod was mounted on the guide outside the patient, misalignment was again confirmed, as the drill bit trajectory fell outside the rod hole.It was also noted that the guide contained impact marks, possibly indicating prior damage or misalignment.The surgeon proceeded with competitor instrumentation, even though the tan rod and three guide wires had already been opened.The surgery was successfully completed after an approximate 30-minute delay.A potential risk of injury, femoral canal fixation with displacement, was described; however, no injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Device was returned and evaluated.H3, h6: results of investigation: two devices were reported and only one was returned and evaluated.The visual inspection revealed that the device (drill guide) presents with heavy wear from use, the threads of the interior shaft are deformed and the post is bent.The exterior of the device is dented, deformed and worn.There are scratches, scuffs and gouges on all surfaces.Furthermore, the damage found in the visual inspection indicates that the device will not function as intended.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the drill guide, of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the rod, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.The rod a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.The drill guide is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: TAN/FAN PERC DRILL GUIDE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23837757
• Report Number: 1020279-2025-02088
• Device Sequence Number: 13083344
• Product Code: HSB
• UDI-Device Identifier: 03596010604873
• UDI-Public: 3596010604873
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 71631021
• Device Lot Number: 17GSP0004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71647436 / LOT: 16DM21637
• Patient Age: 79 YR
• Patient Sex: Female