MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS TGTR 2.5MM TPRD HEX DRVR SHAFT QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 71177008

Device Problem Device Damaged by Another Device (2915)

Patient Problem Rupture (2208)

Event Date 08/24/2022

Event Type  Injury  

Event Description

It was reported that, during an internal fixation surgery, while using the evos small lateral proximal tibia targeter set, both the evos tgtr 2.5mm tprd hex drvr shaft qc and the evos tgtr 2.5mm linear hex drvr shaft qc stripped the screws during insertion.The first osteopenia screw was done on the 2.5 tapered shaft, starting on power, and stripping half way though insertion.This screw was removed with pliers and replaced with a 3.5 cortex screw.That 3.5 screw was inserted on power, with some success, before beginning to strip during final hand tightening.A similar sequence occurred in distal holes of plate.After several screws, the team switched to the linear driver, which was more successful on power, but still stripped on final tightening.Additionally, the evos small tgtr 3.5mm trocar ceased to function properly after first use.After a successful use of the trocar, the ring in the shaft that allows the trocar to retain in the screw guide became misaligned or loosened; hence, the trocar could not be fully inserted into the screw guide.There was also a misalignment at 16h: 13h was targeted, but missed on 16h.The procedure was completed with the same products and/or back-up products without any delay.Patient was not harmed as consequence of the sequence of events.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the devices stripped and/or did not perform as expected during the internal fixation; however, the surgeon was reportedly satisfied with the surgical outcome.A photo was provided of the misaligned trocar ring; however, it did not provide insight into a clinical root cause of the reported event(s).Reportedly, the procedure was completed with the same products and/or back-up products without any delay and patient was not harmed as consequence of the sequence of events.It was communicated that the requested clinical documentation was not available, and the current patient status is unknown.Based on the limited information provided, definitive contributing clinical factors could not be concluded.The patient impact beyond that which was reported cannot be determined as there was no alleged patient injury or surgical delay.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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 product 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.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: EVOS TGTR 2.5MM TPRD HEX DRVR SHAFT QC
• 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: 15426454
• MDR Text Key: 299934040
• Report Number: 1020279-2022-04105
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556639405
• UDI-Public: 885556639405
• 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: Physician
• 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: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71177008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention