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

Model Number 71513331

Device Problem Mechanics Altered (2984)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that the capture mechanism of a universal pin driver grew loose over time.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Event description and health effect: updated.

Event Description

It was reported that, after a knee replacement surgery, the capture mechanism of a universal pin driver grew loose over time and would have become unusable.As this was noticed after surgery, patient was not involved anymore.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirms the tip of the device is loose.This device exhibits signs of significant wear/usage.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIVERSAL PIN DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15271684
• MDR Text Key: 302070329
• Report Number: 1020279-2022-03785
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010589064
• UDI-Public: 03596010589064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 71513331
• Device Catalogue Number: 71513331
• Device Lot Number: 10KM18370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 09/13/2022
• Supplement Dates FDA Received: 08/30/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1