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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, tip of extraction tool broke.
Additional Manufacturer Narrative
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, 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.Referring to the very long period since manufacturing [manufactured in 2010] it is safe to say the device had reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.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 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.It can be classified as an off-label use as per the evidence which suggests that the device was used as a lever despite of the warning "do not lever" clearly marked on the device itself.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, tip of extraction tool broke.

• 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; DE D-24232
• MDR Report Key: 10044642
• Report Number: 0009610622-2020-00193
• Device Sequence Number: 11695394
• Product Code: LXH
• UDI-Device Identifier: 04546540510082
• UDI-Public: 04546540510082
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: K284976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1