MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Model Number	604670S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "asnis iii 4.0 70mm long screw was used for a male tibial distal medial malleolus fracture in his 30s.The bone quality was hard, and the shaft part broke during insertion, making it unusable.I pulled it out and got nothing.The surgeon, who was operated on, is also said to be a technical mistake and does not require a product survey.".
Event or Problem Description
As reported: "asnis iii 4.0 70mm long screw was used for a male tibial distal medial malleolus fracture in his 30s.The bone quality was hard, and the shaft part broke during insertion, making it unusable.I pulled it out and got nothing.The surgeon, who was operated on, is also said to be a technical mistake and does not require a product survey.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The optech instructs user that: ¿contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.Tap/drill ¿ in hard or sclerotic bone, pre-drilling and pre-tapping may be necessary.Cannulated screwdriver with ao fitting ¿ this can be used with either the elastosil handle with ao coupling or a power tool.If a power tool is selected, final tightening must be carried out by hand to prevent stripping.In dense bone, puncturing the cortex with the ø1.4 x 150mm drill bit to initiate the wire may reduce heat build-up and/or deflection of the wire.In dense cortical bone pre-drilling with the cannulated drill ø2.7mm (702449) and use of the cannulated tap ø4.0mm (702454) is recommended, especially when placing oblique screws.¿ 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.However, one of the probable causes of the breakage is application of too high torsional forces by the user in a hard bone of the patient.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X70MM TL23.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11262799
• Report Number: 0008031020-2021-00034
• Device Sequence Number: 13757777
• Product Code: HWC
• UDI-Device Identifier: 04546540089946
• UDI-Public: 04546540089946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/27/2021

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: 06/30/2025
• Device Model Number: 604670S
• Device Catalogue Number: 604670S
• Device Lot Number: G27950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1