MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5045S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
Customer reported a broken gamma nail 3 titanium.On the (b)(6) 2021 the broken gamma nail was removed and a pseudarthrosis treatment was performed (tissue sampling, cleaning of fracture site, re-osteosynthesis with a proximal femoral plate on the lateral side and an ao small fragment plate on the ventral side with spongiosa/filling with bone- chips).A broken screw was also reported.
Additional Manufacturer Narrative
Please note the device was returned, and h6 (method, results and conclusion codes).The reported event was be confirmed.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.No nc/capa had been filed for the item in question.Potential nail breakage had been considered in the risk management file.Potential reasons for nail breakage are listed in the labelling.The screw was completely broken in the approx.In the middle of the shaft.The screw had broken in fatigue manner while positioned in dynamic mode in the oblong drill hole at distal.The cause of the event was determined being exceeding axial load application on the whole construct of implants which was caused by patient and suboptimal fragment reduction by the user.In case further substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.
Event or Problem Description
Customer reported a broken gamma nail 3 titanium.On the (b)(6) 2021 the broken gamma nail was removed and a pseudarthrosis treatment was performed (tissue sampling, cleaning of fracture site, re-osteosynthesis with a proximal femoral plate on the lateral side and an ao small fragment plate on the ventral side with spongiosa/filling with bone- chips) a broken screw was also reported.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 13303789
• Report Number: 0009610622-2022-00029
• Device Sequence Number: 14686935
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 1896-5045S
• Device Catalogue Number: 18965045S
• Device Lot Number: K07B8DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 95 KG