MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-0932S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail (first nail).After that some adjustment was done but the issue did not solve.The physician changed to new different size nail (second nail) and the verification of correct alignment was successful.The procedure was completed without problem using second nail which was different size as the planed size nail.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail (first nail).After that some adjustment was done but the issue did not solve.The physician changed to new different size nail (second nail) and the verification of correct alignment was successful.The procedure was completed without problem using second nail which was different size as the planed size nail.".
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - device was not returned.The alleged event was not confirmed.No other evidence was provided.Review of labelling, capa databases and risk analysis did not identify any new discrepancies.There are no open actions in place related to the reported event for the subject product.It was reported ¿during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail.The physician changed to new different size nail (second nail) and the verification of correct alignment was successful.As the target device had been used successfully in the 2nd surgery it was not suspected being at fault.The nail used during the first calibration was not returned for investigation nor was it reported that it was discarded ¿ thus, it is assumed it is still on stock intended for further use.No further reports regarding inaccurate targeting of the nail lot and referring to nail documentation without deficiency, it was concluded the nail had been distributed according to specifications.With above information the cause of the event was regarded as not device related.Without the returned product for evaluation a root cause for alleged faulty targeting could not be determined.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "during verifying correct alignment by inserting a drill through the sleeve and targeting arm assembly, the drill did not pass through the appropriate hole of the nail (first nail).After that some adjustment was done but the issue did not solve.The physician changed to new different size nail(second nail) and the verification of correct alignment was successful.The procedure was completed without problem using second nail which was different size as the planed size nail.".

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM
• 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: 13418978
• Report Number: 0009610622-2022-00038
• Device Sequence Number: 11934664
• Product Code: HSB
• UDI-Device Identifier: 07613327286489
• UDI-Public: 07613327286489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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 Model Number: 2333-0932S
• Device Catalogue Number: 23330932S
• Device Lot Number: K036203
• Was Device Available for Evaluation?: No
• 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: 05/19/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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
• Patient Sex: Unknown