MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EVOS PLATING INSTR; BIT, DRILL

Catalog Number	UNKNOWN
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case - (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, the drill bound up and broke inside one (1) 2.0/2.7mm double-ended drill guide.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.Device specific identifiers for the drill were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed for the guide.A review of complaint history of the previous 12 months revealed similar events for the listed guide, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified for the guide.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this guide and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.The drill bit is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Double ended drill guides 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.Should the devices 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.

• Brand Name: UNKN EVOS PLATING INSTR
• Common Device Name: BIT, DRILL
• 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: 18120555
• Report Number: 1020279-2023-02219
• Device Sequence Number: 7609329
• Product Code: HTW
• UDI-Device Identifier: 00885556387993
• UDI-Public: 00885556387993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2023
• 2 Devices were Involved in the Event: 1 2

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: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 12/07/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/06/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown