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

Catalog Number 325060S

Device Problems Fracture (1260); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8461804
• MDR Text Key: 140311691
• Report Number: 0008031020-2019-00333
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327078039
• UDI-Public: 07613327078039
• Combination Product (y/n): N
• PMA/PMN Number: K000080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 325060S
• Device Lot Number: Y32516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR