MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG FIN STABILIZER FOR 75000675; PROSTHESIS,HIP,SEMICONSTRAIND,MTALCRAMICPOLYMER,CMNTEDORNONPOROUS,UNCMNTD

Catalog Number	75102261
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polarstem collar case was found broken, a fin stabilizer for 75000675 was found broken, and a easy tray lid plastic was found cracked along its edges.Since this was noticed during a field inspection, no case was involved.
Additional Manufacturer Narrative
H3, h6: it was reported that a fin stabilizer for 75000675 was found broken upon field inspection.The device was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The device is fractured at an edge.The fragment of the device was not returned for evaluation.A review of the complaint history of the affected device was performed.No additional complaints for the batch in question were detected.A review of the production documentation, including the material certificate, did not detect any deviation that could have contributed to the reported failure mode.There is no indication that the device failed to match specification at the time of manufacturing.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The relationship between the reported event and the device was confirmed.Based on the performed investigations, the root cause of the problem remains unknown and is due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.
Event or Problem Description
It was reported that a fin stabilizer for 75000675 was found broken.Since this was noticed during a field inspection, no case was involved.

• Brand Name: FIN STABILIZER FOR 75000675
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAIND,MTALCRAMICPOLYMER,CMNTEDORNONPOROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14403095
• Report Number: 9613369-2022-00260
• Device Sequence Number: 5473835
• Product Code: LZO
• UDI-Device Identifier: 00885556590317
• UDI-Public: 885556590317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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 Catalogue Number: 75102261
• Device Lot Number: A59085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown