MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS; PLATE, FIXATION, BONE

Model Number	71174959
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an olecranon fracture the hook tip of the short depth gauge 2.4mm/2.7mm screws snapped off, instrument inside patient.The entire broken piece was retrieved.Procedure finished with s&n backup device.No surgical delay reported due this event.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per the complaint details, the entire broken piece retained hook tip of the short depth gauge 2.4mm/2.7mm screw was removed.According to the report, the procedure was completed with s&n backup device without a surgical delay.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.A visual inspection confirmed the tip is broken off the short depth gauge 2.4mm/2.7mm screws and has not been returned.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.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 risk management file revealed this failure mode was previously identified.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.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.Internal complaint reference number: case-2021-00040061-1.

• Brand Name: SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11388903
• Report Number: 1020279-2021-01625
• Device Sequence Number: 3742469
• Product Code: HRS
• UDI-Device Identifier: 00885556399545
• UDI-Public: 00885556399545
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71174959
• Device Catalogue Number: 71174959
• Device Lot Number: 14MTRS142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention