MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X60 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1895-5060S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "revision of a retrograde femoral nail due to a broken condyle bolt.All components were removed and another nail was implanted.Surgery date (b)(6) /2022.Another retrograde femoral nail, with 2 screws and 2 bolts were implanted.".
Event or Problem Description
As reported: "revision of a retrograde femoral nail due to a broken condyle bolt.All components were removed and another nail was implanted.Surgery date (b)(6) 2022.Another retrograde femoral nail, with 2 screws and 2 bolts were implanted.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event was confirmed.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.Generally, the received broken condyle screw showed normal signs of usage like typical bearing points.However, the fracture pattern identified a fatigue fracture.Available information revealed the item had been implanted for at least 4 months or more.No further items were reported being broken.As no medical records were provided, an evaluation regarding bone healing was not possible, it was concluded the breakage had been caused by permanent, repeated load application which was classified as patient related.The labelling clearly points out potential causes leading to implant breakage.A product deficiency was not verified.In case further essential information becomes available we reserve the right to re-open the investigation and to re-assess the root cause.
Event or Problem Description
As reported: "revision of a retrograde femoral nail due to a broken condyle bolt.All components were removed and another nail was implanted.Surgery date (b)(6) 2022.Another retrograde femoral nail, with 2 screws and 2 bolts were implanted.".

• Brand Name: CONDYLE SCREW T2 FEMUR Ø5X60 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: 13419039
• Report Number: 0009610622-2022-00039
• Device Sequence Number: 12070353
• Product Code: HSB
• UDI-Device Identifier: 04546540202154
• UDI-Public: 04546540202154
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K014220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 08/31/2021
• Device Model Number: 1895-5060S
• Device Catalogue Number: 18955060S
• Device Lot Number: K0A38D3
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2016
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female