MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1320-0111

Device Problem Failure to Align (2522)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

As reported: "when drilling distally through the targeting device, the screws could not be inserted correctly through the nail afterwards.Although pre-drilled, the screw does not go through the distal nail hole.The 200 gamma3 nail is used here as the standard nail.The procedure was then successfully completed manually.The procedure was delayed by 20 min.".

Manufacturer Narrative

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

Manufacturer Narrative

Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on the fact, that nothing was reported after the last usage in a surgical procedure and pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.In case of any discrepancies in guidance it should have been noticed during time of check which is required per ifu/ operative technique.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited by e.G.- loosening of the nail holding bolt during insertion of the nail - repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended - not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve) - no use of drill with center tip / unfavorable bone contour - drilling without drill guiding sleeve - using blunt or damaged drill - high forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail a review of the device history was not possible because the lot number was not communicated.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.H3 other text : device disposition unknown.

Event Description

As reported: "when drilling distally through the targeting device, the screws could not be inserted correctly through the nail afterwards.Although pre-drilled, the screw does not go through the distal nail hole.The 200 gamma3 nail is used here as the standard nail.The procedure was then successfully completed manually.The procedure was delayed by 20 min.".

• Brand Name: TARGET DEVICE GAMMA3®
• 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: 14599648
• MDR Text Key: 293630402
• Report Number: 0009610622-2022-00221
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• 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: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/05/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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