MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL NAIL EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71751142
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery of removing trigen humeral nail (planned surgery), the mating part on the humeral nail extractor could not keep capturing the screw head.Using a competitor device, the surgery was completed.There was a 30 minutes surgical delay.There was no harm to patient.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms that the threads are damaged causing the stated failure.The device shows signs of significant wear/use.The device was manufactured in 2015.A medical investigation was conducted and it was reported that during a planned removal of the trigen humeral nail, the mating part on the nail extractor would not capture the screw head.The procedure was completed using a competitor device with a 30-minute surgical delay.Per email communication, the requested surgical reports and x-rays are not available.Therefore, no further clinical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 instruments 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.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.

• Brand Name: HUMERAL NAIL EXTRACTOR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10786365
• Report Number: 1020279-2020-06146
• Device Sequence Number: 17054966
• Product Code: HSB
• UDI-Device Identifier: 03596010514776
• UDI-Public: 03596010514776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 71751142
• Device Catalogue Number: 71751142
• Device Lot Number: 15FM00435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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