MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 3.5MM DEPTH GAUGE LONG; PLATE, FIXATION, BONE

Catalog Number	71175068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before a trauma surgery was noticed that the evos small 3.5mm depth gauge long has a piece broken off.There was a smith and nephew back up device to complete the case with no delay and no injury to the patient.
Additional Manufacturer Narrative
Additional information was received for this case.Find new information in section: lot number, expiration date and device manufacture date.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed a piece is broken off the evos small 3.5mm depth gauge long and has not been returned.The device shows significant signs of wear/usage.The device was manufactured in 2017.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.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.

• Brand Name: EVOS SMALL 3.5MM DEPTH GAUGE LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10140722
• Report Number: 1020279-2020-02309
• Device Sequence Number: 2177147
• Product Code: HRS
• UDI-Device Identifier: 00885556635865
• UDI-Public: 885556635865
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71175068
• Device Lot Number: 17MTRS0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 09/09/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/16/2020; 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1