MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NONRIM SPEED PIN 80 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74013490

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that during a trauma surgery, when the lock was made, surgeon realized that (1) one nonrim speed pin 80 sterile was bent when he pinned it and it ended up breaking.The pieces of the broken pin were removed with kelly tweezers.The procedure was resumed, without any delay.Patient was not injured as consequence of this problem.

Manufacturer Narrative

The device was not returned for evaluation.However, the photographs were reviewed, and revealed that the threaded end is fractured.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the label specification, the device should not be reused.However, upon additional dialogue with the customer, it was mentioned that this component was reused.Therefore, the root cause of this event was determined to be the reuse of the single-use device.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.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.

Manufacturer Narrative

The device was not returned for evaluation.However, the photographs were reviewed, and revealed that the threaded end is fractured.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.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.

Event Description

It was reported that during a trauma surgery, when the lock was made, surgeon realized that (1) one nonrim speed pin 80 sterile was bent when he pinned it and it ended up breaking.In addition, a second nonrim speed pin 80 sterile that was in the box, was missing the tip.The pieces of the broken pin were removed with kelly tweezers.The procedure was resumed, without any delay.Patient was not injured as consequence of this problem.

• Brand Name: NONRIM SPEED PIN 80 STERILE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17057027
• MDR Text Key: 316474688
• Report Number: 1020279-2023-01218
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556071397
• UDI-Public: 00885556071397
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2023

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: 74013490
• Device Catalogue Number: 74013490
• Device Lot Number: 16LNX0046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/26/2023; 08/31/2023
• Supplement Dates FDA Received: 06/27/2023; 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female