MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SEMIEXTENDED DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71654524
Medical Device Problem Codes	Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the semi-extended drill guide was found slightly bent and not attaching to the drop properly.Surgeon could not attach the meta-nail anterior drop to the drill guide without using the mallet to gently tap it on.The mallet is not used for this purpose.There was only one set there.No piece of the equipment was left behind in the operating room patient's wound.This held up the case for a few minutes.No injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The locking pin is bent.Also the threads in the device are damaged.The device was manufactured in 2012 and exhibit signs of significant wear/usage.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.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.A review of risk management files found that the reported failure was documented appropriately.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.

• Brand Name: SEMIEXTENDED DRILL GUIDE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10192296
• Report Number: 1020279-2020-02704
• Device Sequence Number: 835400
• Product Code: HSB
• UDI-Device Identifier: 03596010644596
• UDI-Public: 03596010644596
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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
• Report Date (Section B): 10/11/2020

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: 71654524
• Device Catalogue Number: 71654524
• Device Lot Number: 12LCT0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 10/11/2020
• 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: Required Intervention