MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X80MM; SCREW, FIXATION, BONE

Model Number	2361-5080S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a t2 alpha retrograde nail was discovered to be broken at the most proximal screw hole in the distal cluster of the nail.The screw was found to be broken during explantation of the nail.Patient was given weight bearing as tolerated instructions postoperatively.Patient was revised to a t2 scn with endcap.Primary implant date was (b)(6) 2022.Patient took notice on (b)(6), after falling down and feeling pain.Nail has been returned.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a t2 alpha retrograde nail was discovered to be broken at the most proximal screw hole in the distal cluster of the nail.The screw was found to be broken during explantation of the nail.Patient was given weight bearing as tolerated instructions postoperatively.Patient was revised to a t2 scn with endcap.Primary implant date was (b)(6) 2022.Patient took notice on 28-sep, after falling down and feeling pain.Nail has been returned.
Additional Manufacturer Narrative
The reported event that advanced locking screw imn screws ø5x80mm alleged of issue 'implant - breakage post-operative' could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the advanced locking screw was separated by a fatigue fracture.The tip of the screw had not been returned.The appearance of the breakage surfaces identified the screw had broken in fatigue manner ¿ indicated by lines of rest and missing plastic deformation.Dimensional inspection indicates that the device is within the specifications.Furthermore, the material was confirmed by document being in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Two undated x-rays in a-p- and ml-view were provided.They were showing the distal area with condyle locking and nail breakage.1 screw had been placed outside the nail, proximally to the nail breakage.It was concluded this screw had been placed deliberately.Since no other x-rays were available for comparison a medical review was not justified.With available information the root cause for screw breakage could not be determined.If any additional information is provided, the investigation will be reassessed.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X80MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15796659
• Report Number: 0009610622-2022-00504
• Device Sequence Number: 19969959
• Product Code: HWC
• UDI-Device Identifier: 07613327381580
• UDI-Public: 07613327381580
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: Lay User/Patient
• Device Model Number: 2361-5080S
• Device Catalogue Number: 23615080S
• Device Lot Number: K05CB44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female