MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-4107

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that during a tibial nail procedure, the targeter would not allow the screw to engage the nail.The targeting assembly was removed and the screw was implanted free-hand.Surgery was completed successfully with a delay of approximately 10-15 minutes.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Functional check prior to use is required in the labelling ¿ such as ifu, op-tech and re-processing brochure.Simulation of a pre-operative functional check of returned part[s] with sample items revealed no deficiency in targeting accuracy.Reasons for mal alignment are various, e.G.[but not limited to] insufficient tightening of the nail holding screw, applying too much [axial] force on the construct during drilling or unsuitable bone geometry.However, in this case freehand locking was finally performed, which is always an option for distal locking as per operative technique, and procedure was completed successfully.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.With available information a real root cause could not be determined but it could not be excluded that it is rather related to a sub-optimal intraoperative procedure.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

Event Description

It was reported that during a tibial nail procedure, the targeter would not allow the screw to engage the nail.The targeting assembly was removed and the screw was implanted free-hand.Surgery was completed successfully with a delay of approximately 10-15 minutes.

• Brand Name: TARGETING ARM TIBIA T2 ALPHA? TIBIA
• Type of Device: 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: 14427749
• MDR Text Key: 292744202
• Report Number: 0009610622-2022-00187
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 2353-4107
• Device Catalogue Number: 23534107
• Device Lot Number: KME913322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female