MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631451

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/06/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that during surgery the lag screw measurement was incorrect, incorrect size lag screw was subsequently opened and inserted.It was then removed and a more appropriate sized lag screw was inserted.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.The dimensional evaluation concluded that the failure mode could not be duplicated or confirmed.All checks relevant to reported failure mode passed inspection based on the criteria of the inspection drawing.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that per the complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Based on the information provided, the lag screw measurement was incorrect.It was reported the incorrect size lag screw was subsequently opened and inserted.The surgeon subsequently, removed the incorrect lag screw, and he reported, ¿an appropriately sized lag screw was inserted.¿ according to the report, the procedure was completed using a s+n back-up device.Per an e-mail attachment the sales representative reported, ¿this was not a labeling issue.¿ since there was no alleged harmed to this patient or delay in the procedure, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 the risk management file and instructions for use document 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.The contribution of the device to the reported event could not be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of 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.Internal complaint reference: case-2022-00091536-1.

• Brand Name: META-TAN DRILL GUIDE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 13615152
• MDR Text Key: 286238050
• Report Number: 1020279-2022-00879
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556399743
• UDI-Public: 00885556399743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631451
• Device Catalogue Number: 71631451
• Device Lot Number: 16ASP0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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): Other
• Patient Age: 40 YR
• Patient Sex: Male