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

Model Number	71631022
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the tan/fan perc drill guide and the tan/fan perc radilucent drop were very difficult to assemble and disassemble.There was no injuries reported.The procedure was completed with the same device and no significant delays were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection was conducted and confirmed that the tan/fan radilucent drop is damaged which causes it to not function properly.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.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 warranted for this complaint; 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: 11458347
• Report Number: 1020279-2021-01972
• Device Sequence Number: 11706423
• Product Code: HSB
• UDI-Device Identifier: 03596010604880
• UDI-Public: 03596010604880
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631022
• Device Catalogue Number: 71631022
• Device Lot Number: 07FM08169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1