MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6; OSTEOTOME

Catalog Number	75002165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).H10: the revision surgery mentioned on b5 was reported under report number: 9613369-2023-00193.
Event or Problem Description
It was reported that, during a tha revision surgery due to an infection, while attempting to explant an unknown polarstem, the threads of a cs/csl/geradschaft-plus extract.Screw m6 broke in the polarstem.An extended trochanteric osteotomy had to be performed to remove the stem.A winquist removal set was used to lock onto the broken threads but the fixation was too sturdy to pull stem out without breaking the trochanter; it is currently unknown how much of a delay this process caused.All the implanted components were explanted and exchanged for prostalac implants.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip arthroplasty revision surgery due to an infection, while attempting to explant an unknown polarstem, the threads of a cs/csl/geradschaft-plus extract.Screw m6 broke in the polarstem.An extended trochanteric osteotomy had to be performed to remove the stem.A winquist removal set was used to lock onto the broken threads but the fixation was too sturdy to pull stem out without breaking the trochanter; it is currently unknown how much of a delay this process caused.All the implanted components were explanted and exchanged for prostalac implants.The current health status of the patient is unknown.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed 2 additional similar complaints reported for the same batch, and 3 additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of the device labeling revealed that the instructions for use (lit.No.12.23, ed.03/21) states "before use, the functionality of surgical instruments should be checked.The use of damaged instruments may lead to early failure of the implants." as ¿preoperative preparation¿ for instruments before the implantation of a hip prosthesis.A new design of the device has been released in order to reduce the reoccurrence of this issue.This version of the device will be monitored for similar issues.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product.No further escalation is required.Please note that according to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.No clinically sufficient data was provided to perform a medical investigation.The root cause of the event can be attributed to design features of the device that interfere with the intended purpose of the device.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• 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: 17814201
• Report Number: 9613369-2023-00194
• Device Sequence Number: 7249646
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 75002165
• Device Lot Number: A50026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown