MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM; SCREW, FIXATION, BONE

Catalog Number	325060S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Scrub nurse disposed of it.
Event or Problem Description
Customer reported a fracture of distal humerus.Ansis 4.0mm cannulated screw implanted ¿ during implantation the distal threads of the screw appeared to peel away from the core of the screw.Lateral side of elbow opened to remove threads of metal to complete the case.X-rays show a small amount of metal remaining after the majority of the coils were removed.No x-rays available for before any of the metal coil fragments were removed.
Additional Manufacturer Narrative
The reported event could be confirmed only through consulting the provided x-rays.The device was disposed of in the hospital.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Customer reported a fracture of distal humerus.Ansis 4.0mm cannulated screw implanted.During implantation the distal threads of the screw appeared to peel away from the core of the screw.Lateral side of elbow opened to remove threads of metal to complete the case.X-rays show a small amount of metal remaining after the majority of the coils were removed.No x-rays available for before any of the metal coil fragments were removed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8461804
• Report Number: 0008031020-2019-00333
• Device Sequence Number: 13512921
• Product Code: HWC
• UDI-Device Identifier: 07613327078039
• UDI-Public: 07613327078039
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 10/31/2023
• Device Catalogue Number: 325060S
• Device Lot Number: Y32516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR