MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEPTH GAUGE FOR 2.0MM SCREWS; PLATE, FIXATION, BONE

Model Number	71174922
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 after surgery the item broken and unusable.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.Absolutely no broken pieces fell into the patient¿s wound at all and the device did not break over the incision or wound.
Event or Problem Description
It was reported that, after surgery, the item broke and is unusable.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.Absolutely 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, intended for use in treatment, was returned for evaluation.A visual inspection of the returned depth gauge confirms the small ruler assembly end is broke off.The broken piece was not returned with the device.The device shows significant signs of wear/usage.The device was manufactured in 2014.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.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: DEPTH GAUGE FOR 2.0MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10398411
• Report Number: 1020279-2020-03874
• Device Sequence Number: 3551671
• Product Code: HRS
• UDI-Device Identifier: 00885556387399
• UDI-Public: 00885556387399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132886
• 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): 08/27/2020

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: 71174922
• Device Catalogue Number: 71174922
• Device Lot Number: 14LTRS139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1