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

Model Number	71175069
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during surgery.Used an identical backup device to complete surgery.Surgery time was not extended more than 30 min.The surgeon does not fault the device.The patient or surgical procedure was not affected in any way due to the problem.No broken pieces fell into the patient¿s wound at all and the device did not break over the incision or wound.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirms the end of the small ruler sub assembly is broke off.The broken piece was not returned with the device.The device was manufactured in 2017 and it shows signs of significant wear/usage.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 a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EVOS SMALL 3.5MM DEPTH GAUGE SHORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10375887
• Report Number: 1020279-2020-03747
• Device Sequence Number: 16924071
• Product Code: HRS
• UDI-Device Identifier: 00885556635872
• UDI-Public: 00885556635872
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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 Model Number: 71175069
• Device Catalogue Number: 71175069
• Device Lot Number: 17MTRS0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1