MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM DRILL W/QC; PLATE, FIXATION, BONE

Model Number	71173501
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the 2.0mm drill w/qc is delaminated and coming apart.It is unknown where the event occurs and if there was a patient involved.
Additional Manufacturer Narrative
H6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.However, a picture of the device is provided.The picture does confirm the failure mode.The inner walls of the container seems to be delaminating.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.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.

• Brand Name: 2.0MM DRILL W/QC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11094787
• Report Number: 1020279-2020-08005
• Device Sequence Number: 14377170
• Product Code: HRS
• UDI-Device Identifier: 03596010519696
• UDI-Public: 03596010519696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2021

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 Model Number: 71173501
• Device Catalogue Number: 71173501
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 04/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1