MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 IMPACTOR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71368570

Device Problems Break (1069); Degraded (1153); Material Fragmentation (1261)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, one (1) r3 impactor tip broke.Since it was noticed during a field inspection, no patient was involved.

Manufacturer Narrative

B5: describe event or problem.Section h3, h6: the associated device was returned and evaluated.A visual inspection confirms the impactor tip has multiple scratches, pieces chipped off, burrs and gouges in the device.The threads are severely damaged as well.The impactor tip shows signs of extreme wear and use.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 complaint history of the previous 12 months revealed similar events for the listed device, 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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 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.

Event Description

It was reported that, one (1) r3 impactor tip broke.Since it was noticed during a field inspection, no patient was involved.Upon investigation, it was found that tip has multiple scratches, pieces chipped off, burrs and gouges in the device.The threads are severely damaged as well.

• Brand Name: R3 IMPACTOR TIP
• 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: 15592072
• MDR Text Key: 301943172
• Report Number: 1020279-2022-04409
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010600257
• UDI-Public: 03596010600257
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71368570
• Device Catalogue Number: 71368570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1