MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X55MM TL18.5MM; SCREW, FIXATION, BONE

Model Number	325055S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a smooth guide passage of the institution is carried out and when the screw is passed, it is disassembled.A broken screw remains inside the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received asnis screw was found to be broken at the tip region.A broken guide wire is also found stuck inside the cannulation of the screw.Macroscopic view of the threaded portion of the screw reveals signs of severe deformation, abrasion and material chip-off as well.Partial permanent deformation is also evident.It is highly likely that the screw was inserted under immense force to counter hinderance in passing through.A review of the device history for the reported lot did not indicate any abnormalities; the screw was manufactured within specifications.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 the above investigation and the available information, the root cause of the issue is deemed to be user related.The nature of breakage and deformation indicates towards a forceful insertion of the screw inside the bone.Most likely hard dense bone was encountered during insertion, but without patient specific data it cannot be confirmed.However, as per operative technique, the self-cutting and self-tapping tip of the asnis 4.0mm screw is intended for cancellous bone.In dense cortical bone pre-drilling with the cannulated drill and use of the cannulated tap is recommended if any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "a smooth guide passage of the institution is carried out and when the screw is passed, it is disassembled.A broken screw remains inside the patient.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X55MM TL18.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11655847
• Report Number: 0008031020-2021-00148
• Device Sequence Number: 17021991
• Product Code: HWC
• UDI-Device Identifier: 07613327076233
• UDI-Public: 07613327076233
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K000080
• 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): 06/11/2021

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: 05/31/2024
• Device Model Number: 325055S
• Device Catalogue Number: 325055S
• Device Lot Number: B93004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 42