MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN RADILUCENT DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the drill guide is not fitting into the drop due to a broken o ring.Event occurred during use with instruments inside the patient.Procedure was completed using a sn backup device.A delay of less than 30 minutes was reported.Any other issue that could affect the patient's condition was not reported by this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed the device shows significant signs of wear/usage.A functional evaluation was conducted and confirms per inspection of the returned complaint device, the part is 3 years old and exhibits signs of minimal wear/usage.It is visually noticeable that one of the o-rings is broken, preventing the drill guide from engaging correctly with the drop.The o-ring has broken due to multiple uses, possibly damaged during previous surgery.Nothing indicates that the device left s+n with this defect as they are inspected 100% at final inspection, as well as assembly.A medical investigation was conducted and confirms although the provided report indicated the o-ring broke during use of the instrument inside the patient, it was reported the procedure was completed using an s&n backup device.Since there was no alleged harm to the patient because of the delay of less thirty minutes delay, no further clinical/medical assessment is warranted at this time.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TAN/FAN RADILUCENT DROP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10423157
• Report Number: 1020279-2020-04027
• Device Sequence Number: 16891905
• Product Code: HSB
• UDI-Device Identifier: 03596010604880
• UDI-Public: 03596010604880
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631022
• Device Catalogue Number: 71631022
• Device Lot Number: 18KM04996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention