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

Model Number	75002165
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during thr, cs/csl/geradschaft-plus extract.Screw m6 sheared off while it was being screwed into the polarstem extractor block.It is unknown how the problem was solved.Patient was not harmed as consequence to this problem.
Additional Manufacturer Narrative
Further review of this case indicates this is a duplicate report.The event in this report has been already reported under mdr no.Case (b)(4).All further communication for this event will be managed in that case, including a follow up report with the results of our investigation.We respectfully request to close the case as a duplicate and refer to the referenced case above.

• 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: 12268442
• Report Number: 9613369-2021-00340
• Device Sequence Number: 12027444
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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