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

Model Number	71654524
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the meta nail semi extended drill guide broke.Instrument was inside of the patient.It is unknown how surgery was completed and if it was delayed.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device was broken along the weld, rendering the device inoperative.The device shows signs of extensive use.A medical investigation was conducted and confirms it has not been reported whether any pieces from the broken meta nail semi-extended drill were retained/ and or retrieved from the patient.No clinically relevant supporting documentation was provided for review.Based on the limited information provided the root cause of the breakage could not be determined.If a portion of the meta nail semi-extended drill remains retained in the patient, it is made of a non-implantable material.If pieces were retained, we cannot rule out the potential for tissue inflammation, pain, micro-motion and/or migration.Based on the information provided, it is unknown how surgery was completed or if it was delay in the procedure.Since there was no patient harm reported, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 11720742
• Report Number: 1020279-2021-03393
• Device Sequence Number: 3091873
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71654524
• Device Catalogue Number: 71654524
• Device Lot Number: UKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 08/14/2021
• 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