MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X28MM TL9.5MM; SCREW, FIXATION, BONE

Model Number	325028S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It is reported that the product "snapped in half whilst it was being inserted with the screwdriver." update: "the surgery was completed successfully as we used more than one kit and a selection of plates and screws not just the cannulated ones.There was a minimal delay." additionally, it was reported; the procedure was extended however the length of the extension is unknown.
Additional Manufacturer Narrative
The reported event could be confirmed, since the damaged screw is visible on the received picture.The picture was reviewed, the broken cannulated screw is visible on the picture, the complete threaded part at the forefront is not present anymore, the fragment is not visible on the picture.No further evaluation is possible due to the low quality of the picture and as the affected device was not returned for inspection.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It is reported that the product "snapped in half whilst it was being inserted with the screwdriver" update - "the surgery was completed successfully as we used more than one kit and a selection of plates and screws not just the cannulated ones.There was a minimal delay." additionally, it was reported; the procedure was extended however the length of the extension is unknown.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X28MM TL9.5MM
• 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: 15144749
• Report Number: 0008031020-2022-00370
• Device Sequence Number: 5226252
• Product Code: HWC
• UDI-Device Identifier: 07613327075991
• UDI-Public: 07613327075991
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213199
• 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
• Report Date (Section B): 10/14/2022

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 Expiration Date: 04/30/2024
• Device Model Number: 325028S
• Device Catalogue Number: 325028S
• Device Lot Number: B91275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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
• Patient Sex: Unknown