MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM LONG AO PILOT DRILL; PLATE, FIXATION, BONE

Catalog Number	71631121
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/28/2024
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 related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or 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 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 during internal fixation surgery, one (1) 4.0mm long ao pilot drill broke while drilling for the proximal screw, a second (2) drill bit from the set was used and also broke.The surgeon then resorted to a reconstruction locking system.It was noticed that the drill bits were hitting the nail and causing breakage.Both tips were not removed from the patient.The reconstruction mode was performed without problems and the case was completed.It is unknown how was completed and if there was any delay.
Additional Manufacturer Narrative
Additional information: h6 (type of investigation), h10 (roi).H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without the return of the device for evaluation, the definitive clinical root cause of the reported drill bit breakages could not be determined.Although we cannot rule out improper alignment, positioning, poor fluoroscopic visualization, inadequate bone exposure or product reuse as possible contributing factors or instrumentation.The non-implantable 4.0mm long ao pilot drill bits are comprised of stainless steel.The 4.0 mm long ao pilot drills are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Since the drill bits were retained in the patient¿s bone, micro-motion/migration is unlikely.The patient impact is the retained tips and the procedure change.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase the risk of breakage, failure, patient infection, patient injury and revision surgery.A review of the risk management file 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 product and event.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 the device or 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.We consider this investigation closed.B5, h6 (health effect - impact code).
Event or Problem Description
It was reported that during internal fixation surgery, one (1) 4.0mm long ao pilot drill broke while drilling for the proximal screw.The surgeon then resorted to a reconstruction locking system.It was noticed that the drill bit was hitting the nail and causing breakage.The tip not removed from the patient.The procedure was able to be completed with the same device.Surgery was not delayed.Patient was not harmed.

• Brand Name: 4.0MM LONG AO PILOT DRILL
• Common Device Name: PLATE, FIXATION, BONE
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21157859
• Report Number: 1020279-2025-00112
• Device Sequence Number: 8419540
• Product Code: HRS
• UDI-Device Identifier: 03596010497468
• UDI-Public: 3596010497468
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123055
• 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): 03/07/2025

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: 71631121
• Device Lot Number: 24BSZ0105
• 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: 12/28/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown