MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3907
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that one advanced locker missed the lateral oblique hole.The first drill pass hit a tine of a large weber clamp possibly affecting the trajectory of the screw.The surgeon used a regular locker and insertion went completely normal.
Additional Manufacturer Narrative
The alleged event, instrument ¿ misdrilling, was not confirmed since no item was returned because still in use.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 ¿one advanced locker missed.The first drill pass hit a tine of a large weber clamp possibly affecting the trajectory of the screw.We ended up having to use a regular locker and insertion of that went completely normal." the labelling points out ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿.Reading the rep¿s reply it was concluded the event was not caused by a deficiency of the device, which still is in use.Considering that another product was hit accidentally the event was rather caused by an unintended use error.With above information the cause of the event was regarded as user related event - not product related.
Event or Problem Description
It was reported that one advanced locker missed the lateral oblique hole.The first drill pass hit a tine of a large weber clamp possibly affecting the trajectory of the screw.The surgeon used a regular locker and insertion went completely normal.

• Brand Name: DISTAL TARGETING DEVICE FEMUR RETROGRADE
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12456415
• Report Number: 0009610622-2021-00685
• Device Sequence Number: 16439015
• Product Code: HSB
• UDI-Device Identifier: 07613327411843
• UDI-Public: 07613327411843
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• 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): 12/21/2021

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: 2353-3907
• Device Catalogue Number: 23533907
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown