MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6172
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
"the customer reported that whilst attempting to extract a cannulated hip screw out of a patient, a piece of the instrument sheared off into the cannulated screw.".
Additional Manufacturer Narrative
D9 corrected product return details; h3 corrected to indicate device was evaluated by manufacturer.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received conical extractor was found to be broken from the tip area.The tip broke approximately from the 3rd thread from the transition.The broken tip was not received for evaluation.The breakage appears to be slightly oblique, which typically indicates towards levering of the instrument.Similar thing happened here most likely, the tool was used as a lever, even though a warning has been laser marked ¿do not lever¿.The breakage surface shows signs of typical brittle fracture smooth topography, no plastic deformation and abrupt breakage towards the end.The tip broke due to a bending overload.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The breakage of the conical extractor happened most likely due to a bending overload applied during the surgery resulting in a brittle fracture, evident by the breakage surface.Under such a situation, a device encounters a lot of stress (along with the residual stress over a long period of use) which leads to a sudden breakage (brittle), as in this case.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
"the customer reported that whilst attempting to extract a cannulated hip screw out of a patient, a piece of the instrument sheared off into the cannulated screw.".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11448980
• Report Number: 0009610622-2021-00347
• Device Sequence Number: 17155897
• Product Code: LXH
• UDI-Device Identifier: 04546540510082
• UDI-Public: 04546540510082
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 1806-6172
• Device Catalogue Number: 18066172
• Device Lot Number: KSS165638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1