MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III SCREWS Ø6.5/8.0MM LARGE AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702624
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the key broke when trying to remove it from the screw inside the patient.No additional information is available regarding if any debris was left behind in the patient.
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 the procedure the key broke when trying to remove it from the screw inside the patient.No additional information is available regarding if any debris was left behind in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device, was returned and matches alleged failure.The device inspection revealed the following: the returned extractor screwdriver is broken from the tip, and the tip was not returned.From the microscopic image, it is clear that the fracture is brittle in nature and broken due to the application of torsional aspects.In the fractured area, we can see rust formation as started which is due to reprocessing after breakage.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 the investigation, the root cause was attributed to being user related.By application of a high torsional load, leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during the procedure the key broke when trying to remove it from the screw inside the patient.No additional information is available regarding if any debris was left behind in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device, was returned and matches alleged failure.The device inspection revealed the following: the returned extractor screwdriver is broken from the tip, and the tip was not returned.From the microscopic image, it is clear that the fracture is brittle in nature and broken due to the application of torsional aspects.In the fractured area, we can see rust formation as started which is due to reprocessing after breakage.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 the investigation, the root cause was attributed to being user related.By application of a high torsional load, leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.

• Brand Name: EXTRACTOR ASNIS III SCREWS Ø6.5/8.0MM LARGE AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15886400
• Report Number: 0008031020-2022-00661
• Device Sequence Number: 5113652
• Product Code: LXH
• UDI-Device Identifier: 04546540112873
• UDI-Public: 04546540112873
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 702624
• Device Catalogue Number: 702624
• Device Lot Number: 15539Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2019
• 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: Male