MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL PIN DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71513331
Medical Device Problem Codes	Material Fragmentation (1261); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, two (2) universal pin drivers failed to hold the profix bone spikes, both cracked while the surgeon placed the pins into the a/p block.Pieces of the devices were retrieved but it is unknown how.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.Also, a genesis ii posterior stabilized constrained housing reamer dome have become dull and did not ream well.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.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 complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIVERSAL PIN DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12307366
• Report Number: 1020279-2021-06289
• Device Sequence Number: 14370281
• Product Code: LXH
• UDI-Device Identifier: 03596010589064
• UDI-Public: 03596010589064
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 71513331
• Device Catalogue Number: 71513331
• Device Lot Number: 18BM18534
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1