MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM; SCREW, FIXATION, BONE

Model Number	604644S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Customer reported that: "during removal of osteosynthesis material from the patient's right ankle, one of the screws broke into fragments.Need to open specific material for broken screws.Enlargement of the screw hole.Lengthening of the intervention time (20-25 minutes).No consequences for the patient.Dm preserved and can be made available for expertise." (b)(6) 2023: clarification regarding enlargement of screw hole, the customer reported, "in order to remove the screw, we had to dig a tunnel around it.".
Additional Manufacturer Narrative
Please note correction to d1.The reported event could be confirmed.The device inspection revealed the following: the returned screw is highly bent and twisted, major scratches are visible on its shaft.The screw head and the shaft part below it were broken into multiple fragments, the fragments were returned.The deformation as well as the uneven fracture surface give indication of a gradual ductile fracture.Due to broken head it was not possible to read the catalog # and the lot # marked on the implant.The implant deformation and breakage are most probably a result of excessive torsional and bending load.The scratches observed on the implant shaft occurred most probably during the extraction.Dimensional inspection showed the device to be within specification.Since no x-ray was sent for investigation and no further detailed information was provided, it was not possible to precisely define how and when the breakage of the implant occurred, if it happened while the screw was implanted in the patient or if it happened during the explantation.Therefore, it was not possible to determine the possible root cause of the breakage.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.If more information is provided, the case will be reassessed.
Event or Problem Description
Customer reported that: "during removal of osteosynthesis material from the patient's right ankle, one of the screws broke into fragments.Need to open specific material for broken screws.Enlargement of the screw hole.Lengthening of the intervention time (20-25 minutes).No consequences for the patient.Dm preserved and can be made available for expertise." 22 feb 2023: clarification regarding enlargement of screw hole, the customer reported, "in order to remove the screw, we had to dig a tunnel around it.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16479098
• Report Number: 0008031020-2023-00103
• Device Sequence Number: 7521338
• Product Code: HWC
• UDI-Device Identifier: 04546540089809
• UDI-Public: 04546540089809
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213199
• 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): 05/30/2023

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 Expiration Date: 06/30/2026
• Device Model Number: 604644S
• Device Catalogue Number: 604644S
• Device Lot Number: H43563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown