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

Model Number	75002165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a revision surgery, the threaded inserter of the cs/csl/geradschaft-plus extract.Screw m6 broke off within the polarstem that was meant to be removed.The femur was cracked to remove the stem that contained the fractured piece.Surgery was delayed less than 30 min as a consequence.The current health status of patient is unknown.
Event or Problem Description
It was reported that, during a revision surgery, the threaded inserter of the cs/csl/geradschaft-plus extract.Screw m6 broke off within an accolade stem that was meant to be removed.This instrument is not compatible to remove competitor products.The femur was cracked to remove the stem that contained the fractured piece.Surgery was delayed less than 30 min as a consequence.The patient is doing well.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a revision surgery, the threaded inserter of the cs/csl/geradschaft-plus extract.Screw m6 broke off within an accolade stem that was meant to be removed.This instrument is not compatible to remove competitor products.The femur was cracked to remove the stem that contained the fractured piece.Surgery was delayed less than 30 min as a consequence.The patient is doing well.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 modes.The performed complaint history review for the complaint device revealed no previous complaints for the same batch.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.A new design of the device has been released in order to reduce the reoccurrence of the alleged issue, this version of the device will be monitored for similar issues.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the instructions for use states "implant and implant components of smith & nephew orthopaedics ag must not be combined with other manufacturer implants, unless the implant combination is listed in the relevant surgical technique.Further, they should always be implanted using smith & nephew orthopaedics ag surgical instruments." in the section ¿combination restrictions of smith & nephew products with third-party products¿, for the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.Based on the information provided to the complaint, it is not possible to confirm the reported failure modes.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.The need for corrective action is not indicated.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.Internal complaint reference number: (b)(4).

• 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: 15635203
• Report Number: 9613369-2022-00583
• Device Sequence Number: 5797829
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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: 75002165
• Device Catalogue Number: 75002165
• Device Lot Number: A69573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/17/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 10/24/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown