MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Model Number	325070S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Laceration(s) (1946); Nerve Damage (1979)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "an asnis 4.0 screw was inserted into a patients medial epicondyle.The screw de-threaded and some of the threads ended up in the patients cubital fossa which caused a laceration to the radial nerve.".
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.H3 other text : device discarded.
Event or Problem Description
As reported: "an asnis 4.0 screw was inserted into a patients medial epicondyle.The screw de-threaded and some of the threads ended up in the patients cubital fossa which caused a laceration to the radial nerve.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the evidence received.A x-ray was received for investigation, confirming the reported event.It could be observed that the cannulated screw is heavily bent and that the threaded tip is fragmented.However, it was not possible to determine if the deformation of the implant was intentional or not and if it had an influence on the fragmentation of the thread.It was not possible to determine the root cause of the event.More information as well as the return of the device are necessary for a deeper investigation.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.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM
• 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: 17049920
• Report Number: 0008031020-2023-00211
• Device Sequence Number: 19677292
• Product Code: HWC
• UDI-Device Identifier: 07613327076257
• UDI-Public: 07613327076257
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 325070S
• Device Catalogue Number: 325070S
• Device Lot Number: C14585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown