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

Model Number	75002165
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem Description
It was reported that these cs/csl/geradschaft-plus extract.Screw m6 were found defective.One was found to be bent and a thread came off from the other one.It was reported that the failures occurred during use and a change in surgical technique was necessary in order to complete the procedure.Section was used to retrieve metal shavings.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that one m6 extraction screw (75002165) was found bent prior to surgery.Therefore, another m6 extraction screw was used.However, that one broke during surgery.In order to remove the stem, a third unknown device was used, which was reported to be heavily worn after the procedure.This complaint discusses the m6 extraction screw which broke during surgery.The part, used in treatment was not returned for evaluation.Therefore no visual inspection could be conducted, the relationship between the reported event and the device can therefore not be confirmed.Furthermore, no batch number was communicated.The production documentation could not be reviewed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Several further complaints were reported for the part in scope, however it was shown that the occurrence and the severity are covered through the corresponding risk management files.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.No probable root cause can be determined.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.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.

• 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
• MDR Report Key: 11347078
• Report Number: 9613369-2021-00074
• Device Sequence Number: 4117806
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention