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

Model Number	75002165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr the surgeon used the cs/csl/geradschaft-plus extract.Screw m6 with the extraction block to implant a stem.Upon malleting upwards the tip of the extractor broke off.Surgeon decided to leave the stem in place.Instruments inside the patient.All pieces were removed.The procedure was completed without delay with a change in surgical technique.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr the surgeon used the cs/csl/geradschaft-plus extract.Screw m6 with the extraction block to extract a stem.The tip of the extractor broke off, the surgeon decided to leave the stem in place and the instruments inside the patient.All pieces were removed.The procedure was completed without delay with a change in surgical technique.No patient injury or other complications were reported.The complaint part, used in treatment, was received for investigation.The reported issue could be confirmed upon visual inspection.The production documentation was reviewed, no deviations from the standard manufacturing procedure were found.The complaint history review was performed.3 further complaints were found for the lot a58959 reporting fractured tips.The risk management review was performed, the severity and the failure mode are covered through our risk management.A risk assessment for this failure mode was performed.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments be routinely inspected for wear and damage and replaced as necessary.For the medical investigation, it is noted that no operative reports are available.No further medical assessment is warranted at this time.Based on the performed investigations, the reported fracture of the instrument was confirmed.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.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.No further actions are deemed necessary.The complaint device 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
• MDR Report Key: 11553372
• Report Number: 9613369-2021-00121
• Device Sequence Number: 14409863
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75002165
• Device Catalogue Number: 75002165
• Device Lot Number: A58959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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: Hospitalization; Other; Required Intervention