MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RIM SPEED PIN 45MM STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74013471

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2020

Event Type  Injury  

Event Description

It was reported that during total knee arthroplasty the speedpin head worn away, making it impossible to remove from the cutting block with a drill.A pin puller was used to twist it out.There was a delay reported of less than or equal to 30 minutes.The procedure was finished using a smith and nephew backup device.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports the head of the speedpin wore away, making it necessary to use a pin puller to twist it out of the cutting block, as it could not be removed with the drill.Per email communication, there was no patient injury, and the procedure was completed using a backup device, with minimal delay.Therefore, since no patient harm is alleged, no further clinical assessment is necessary.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 risk management file revealed this failure mode was previously identified.Damage from misuse or rough handling are likely probable causes of the reported event.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: RIM SPEED PIN 45MM STERILE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10840403
• MDR Text Key: 216305187
• Report Number: 1020279-2020-06445
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556069981
• UDI-Public: 00885556069981
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74013471
• Device Catalogue Number: 74013471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention