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

Model Number	74013471
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10840403
• Report Number: 1020279-2020-06445
• Device Sequence Number: 3799626
• Product Code: HSX
• UDI-Device Identifier: 00885556069981
• UDI-Public: 00885556069981
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 74013471
• Device Catalogue Number: 74013471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 04/16/2021
• 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; Required Intervention