MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	71174924
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unspecified surgery, the 1.5/2.0mm double-ended drill guide was sticking on the drill, and was not going through smoothly.The procedure was finished using a smith and nephew back up device with no surgical delay and no injury to patient.
Additional Manufacturer Narrative
Find additional information received for this case in sections: d4 (lot number and expiration date) and h4.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed the 1.5/2.0mm double-ended drill guide is bent, which would cause the device not to function as intended.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10077556
• Report Number: 1020279-2020-01821
• Device Sequence Number: 3792119
• Product Code: FZX
• UDI-Device Identifier: 00885556387498
• UDI-Public: 885556387498
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71174924
• Device Lot Number: 15ATD0003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 08/21/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/12/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1