MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.3MM CANN COUNTERSINK W/QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71177188

Device Problem Dull, Blunt (2407)

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

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported that the 1.3mm cann countersink w/qc is dull and needs to be replaced.The device was found defective during surgery.A stryker 4.0mm cannulated screw (competitor's device) was used in order to complete the procedure.No surgical delay or injury to the patient was reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, the device was dull; therefore, a competitor device was required to proceed with the procedure.Per correspondence, the requested reports were not available.S+n recommends thorough inspection of instruments prior to use and instructs to replace worn instrumentation; therefore, the reported event likely represents wear from usage and likely does not represent a malfunction of the instrument.Since no patient injury or surgical delay was reported, no further medical assessment is warranted at this time.A complaint history review found related failures; 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: 1.3MM CANN COUNTERSINK W/QC
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11573366
• MDR Text Key: 242375403
• Report Number: 1020279-2021-02399
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556017197
• UDI-Public: 00885556017197
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71177188
• Device Catalogue Number: 71177188
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention