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

Model Number	1806-6169
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during an extraction procedure all rods and unbroken screws were successfully extracted.The surgeon decided to use a conical extractor to remove the remaining screw in the l1 right pedicle which resulted in the tip of the conical extractor breaking off inside a es2 screw.The surgery was completed with the broken es2 screw and the tip of the conical extractor left inside the body.
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.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material 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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that during an extraction procedure all rods and unbroken screws were successfully extracted.The surgeon decided to use a conical extractor to remove the remaining screw in the l1 right pedicle which resulted in the tip of the conical extractor breaking off inside a es2 screw.The surgery was completed with the broken es2 screw and the tip of the conical extractor left inside the body.

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET SMALL
• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15336502
• Report Number: 0009610622-2022-00406
• Device Sequence Number: 6890276
• Product Code: LXH
• UDI-Device Identifier: 04546540510051
• UDI-Public: 04546540510051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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: 1806-6169
• Device Catalogue Number: 18066169
• Device Lot Number: KSS1940H6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female