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

Model Number	75002165
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, two (2) cs/csl/geradschaft-plus extract.Screw m6 broke.It is unknown whether the event happened during internal or external use to patient and if there was a delay as consequence of this allegation; therefore, it is unknown the patient current health status.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, two (2) cs/csl/geradschaft-plus extract.Screw m6 broke.It is unknown whether the event happened during internal or external use to patient and if there was a delay as consequence of this allegation; therefore, it is unknown the patient current health status.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted, and the reported failure mode could not independently be confirmed.The batch number of this device was not communicated and a review of the batch record could not be conducted.A complaint history review was performed, the complaint is in line with the current risk management file.Review of past corrective actions was performed.No further escalation is required.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met 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.No probable cause can be determined.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 receive.
Event or Problem Description
It was reported that, during a thr surgery, the threads of one (1) cs/csl/geradschaft-plus extract.Screw m6 broke off.It is unknown whether the event happened during internal or external use to patient and if there was a delay as consequence of this allegation; therefore, it is unknown the patient current health status.
Additional Manufacturer Narrative
Additional information: d4, h4 h3, h6: it was reported that, during a thr surgery, one cs/csl/geradschaft-plus extract.Screw m6 broke.It is unknown whether the event happened during internal or external use to patient and if there was a delay as consequence of this allegation; therefore, it is unknown the patient current health status.Upon visual inspection, it can be confirmed that the thread of the device is broken off.Further signs of use are visible.The production documentation of the returned device was reviewed, however there were no deviations found.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Four additional complaints were reported for the batch in scope.The failure mode and the severity are covered through smith and nephew¿s risk management files.The root cause is attributed to a design issue.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.To date, based on the available information, the need for further actions is not indicated.Smith and nephew will monitor the devices for further similar issues.The returned device will be discarded.B5.

• 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: 12820149
• Report Number: 9613369-2021-00406
• Device Sequence Number: 12154681
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2022

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 Model Number: 75002165
• Device Catalogue Number: 75002165
• Device Lot Number: A51344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 06/07/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/24/2021; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• 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
• Patient Sex: Unknown