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 Codes	Break (1069); Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "used timex extraction kit for proximal humeral nail removal.The nail would not come out using the usual conical extractor.The male extractor 4mm was used to try clear bone inside the nail and broke whilst trying to extract nail.The broken part remains in the nail.Unable to extract nail and had to leave the nail in patient.Nb: the male extractor would not usually be used in this situation however nothing else was working therefore it was attempted to force the nail out in other ways.The patient had already been on the table for approximately 2 hours trying to extract the nail before the male extractor broke.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "used timex extraction kit for proximal humeral nail removal.The nail would not come out using the usual conical extractor.The male extractor 4mm was used to try clear bone inside the nail and broke whilst trying to extract nail.The broken part remains in the nail.Unable to extract nail and had to leave the nail in patient.Nb: the male extractor would not usually be used in this situation however nothing else was working therefore it was attempted to force the nail out in other ways.The patient had already been on the table for approximately 2 hours trying to extract the nail before the male extractor broke." additional information: the patient wanted it removed as they had discomfort when raising their arms up, it was thought the nail was not buried enough however once opened, the top of the nail was firmly buried beneath bone.It was a planned removal due to patient discomfort and the surgeon is not planning to make another attempt to remove the nail.
Event or Problem Description
As reported: "used timex extraction kit for proximal humeral nail removal.The nail would not come out using the usual conical extractor.The male extractor 4mm was used to try clear bone inside the nail and broke whilst trying to extract nail.The broken part remains in the nail.Unable to extract nail and had to leave the nail in patient.Nb: the male extractor would not usually be used in this situation however nothing else was working therefore it was attempted to force the nail out in other ways.The patient had already been on the table for approximately 2 hours trying to extract the nail before the male extractor broke.".Additional information: the patient wanted it removed as they had discomfort when raising their arms up, it was thought the nail was not buried enough however once opened, the top of the nail was firmly buried beneath bone.It was a planned removal due to patient discomfort and the surgeon is not planning to make another attempt to remove the nail.
Additional Manufacturer Narrative
Please note the correction to h1 type of reportable event.The reported event could be confirmed since the device was returned and matches the alleged failure.The visual inspection of the received device shows the distal end is out of shape.From the microscopic view of the damaged surface which clears that the breakage is brittle in nature and was caused by the application of excessive force.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to an off-label use as device is meant to be used for removal of screws and not nails.If any additional information is provided, the investigation will be reassessed.

• 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
• 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: 16832221
• Report Number: 0009610622-2023-00139
• Device Sequence Number: 15236812
• Product Code: LXH
• UDI-Device Identifier: 04546540510068
• UDI-Public: 04546540510068
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: KSS22715E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 05/10/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/05/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown