MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported to the sales rep that: "during my last intervention of the day, i had to try to remove some old screws from a foot.During this attempt, i first used the appropriate screwdriver, but unfortunately the thread did not hold and this damaged the thread, making it impossible to remove them.I then asked for the universal extraction tool.This time i was able to get a grip, but the hardware broke.I used the size above, but again the material broke.So i had to cut the bone around the treffin screws, which made the operation very complicated and the result very uncertain.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the tip of the extractor is partly broken off.The broken off piece was not returned for investigation.The breakage surface shows the typical structure of a brittle fracture due to bending overload.The extractor is laser marked with the warning ¿do not lever¿, however by the look of breakage surface it¿s clearly levered from the tip thread region.No further visible damage is found.As per the dimensional inspection & hardness test results, the returned device was found to be within specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by high bending stress & torsional overload.The material is hardened to be harder than the screws (the hard cutting edges of the extractor cut its own thread into the screw head).Hardened materials are brittle and rather break than bend.Therefore it is not allowed to bend the extractor i.E.Using it as lever arm.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported to the sales rep that : "during my last intervention of the day, i had to try to remove some old screws from a foot.During this attempt, i first used the appropriate screwdriver, but unfortunately the thread did not hold and this damaged the thread, making it impossible to remove them.I then asked for the universal extraction tool.This time i was able to get a grip, but the hardware broke.I used the size above, but again the material broke.So i had to cut the bone around the treffin screws, which made the operation very complicated and the result very uncertain.".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 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: 11076932
• Report Number: 0009610622-2020-01062
• Device Sequence Number: 11513327
• Product Code: LXH
• UDI-Device Identifier: 04546540510068
• UDI-Public: 04546540510068
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 1806-6170
• Device Catalogue Number: 18066170
• Device Lot Number: KSS1850RS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 04/23/2021
• 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