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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a thr, a cs/csl/geradschaft-plus extract.Screw m6 broke off when threaded onto the proximal part of the implant.Furthermore, all pieces were recovered, however no x-rays are available.Surgery was resumed, without any delay, with the same device.No patient harm was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement, a cs/csl/geradschaft-plus extract.Screw m6 broke off when threaded onto the proximal part of the implant.Furthermore, all pieces were recovered, however no x-rays are available.No patient harm was reported.The complaint device used in treatment has not been completely returned.A visual evaluation of the returned part was conducted, and it was concluded that the the tip of the device is fractured and the fragment was not returned.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The review of historical complaints for the alleged device revealed 18 additional similar complaints reported for the same batch, and 4 additional similar complaints for the same product number over the past 12 months with similar failure mode.The root cause is attributed to design constraints.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.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.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned devices will be discarded.

• 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: 17410914
• Report Number: 9613369-2023-00172
• Device Sequence Number: 9025614
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 75002165
• Device Lot Number: A56049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2015
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown