MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GAP SPACER; TEMPLATE

Model Number 71935180

Device Problem Material Fragmentation (1261)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that, during a uka procedure, assisted by cori, when a gap spacer was inserted and the surgeon trialed for stress rom, the device shattered.It is unknown how the procedure was completed or if the patient was affected by this event.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.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 device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 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 uka procedure, assisted by cori, when a gap spacer was inserted and the surgeon trialed for stress rom, the device shattered, but no piece fell into the wound.The procedure was resumed, without any delay and no back-up was required.Patient was not harmed as consequence of this problem.

• Brand Name: GAP SPACER
• Type of Device: TEMPLATE
• 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: 16985847
• MDR Text Key: 315777252
• Report Number: 1020279-2023-01103
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556578445
• UDI-Public: 00885556578445
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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: 71935180
• Device Catalogue Number: 71935180
• Device Lot Number: 21FDN4648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1