MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø10X400 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18251040S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Porduct disposition is unknown.
Event or Problem Description
It has been reported that a t2 nail has broken during surgery.
Event or Problem Description
It has been reported that a t2 nail has broken during surgery.
Additional Manufacturer Narrative
Evaluation revealed the t2 femoral nailing to be the primary product.All other mentioned products (locking screws and end cap) are regarded to be concomitant products.Physical investigation of the nail was not possible as it was not available for investigation even being requested.A review of the dhr revealed no discrepancies in material or manufacturing.The device was documented as faultless prior to distribution.Thus, we exclude deviations in material and manufacturing.The ifu includes that obesity, traumatic overloads and non-unions can lead to implant failures like breakages.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.With regard to the available information a more precise statement is not possible.The file will be closed formally and we reserve the right to reopen the file in case the device and / or further information becomes available.
Event or Problem Description
It has been reported that a t2 nail has broken during surgery.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø10X400 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; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5876680
• Report Number: 0009610622-2016-00406
• Device Sequence Number: 26114
• Product Code: HSB
• UDI-Device Identifier: 04546540199539
• UDI-Public: 0104546540199539111603161721022810K0C7F7191K0C7F71
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 02/28/2021
• Device Catalogue Number: 18251040S
• Device Lot Number: K0C7F71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2016
• 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: Other
• Patient Sex: Unknown