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

Catalog Number 13200111

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dynamic distal locking with the target device.Drilling / screw dorsal of the nail.Locking by hand without target device.Surgical delay of 15 min.Not longer.No other consequences reported.

Manufacturer Narrative

Evaluation revealed the target device as primary product.The speedlock sleeve returned was regarded as associated product.Appearance of item and inspection records identified the target device returned being of new design version.Deviations in the inspection documents were not found.A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery.Functional test revealed neither proximal ¿ nor distal contacts of the drill to the drill holes of the sample nail.Although damaged the function of the target device returned was fully given.The reported event that the gamma3 target device was alleged of causing distal missdrilling during medical procedure could not be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation, it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check, it was concluded that the event(s) were mainly based in the intra-operative procedure.Reasons for misaligned drilling and misaligned distal locking screws are various.Potential miss-targeting can also be caused but is not limited by e.G.Ensure that the nail holding bolt is still fully tightened avoid soft tissue pressure on the distal locking sleeve assembly- therefore the skin incision would be made (co-linear) in direction of the sleeve assembly check that the distal locking sleeve assembly with the trocar removed is in contact with the lateral cortex of the femur and is locked securely with the speedlock sleeve knob.Confirm final locking screw placement with a/p and lateral fluoroscopic x-ray.Neutralize the power tool weight during drilling procedure and do not apply force to the targeting arm start the power tool before having bone contact with the drill use sharp and center tipped drills only regarding misdrilling the operative technique has already been modified by ecn.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and thus user related.The event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard.The collateral finding ¿ damage at the metal nail adapter in the area where the strike plate can be attached is due hammering onto a ball tip screwdriver into the reception for the strike plate and thus user related.Investigation revealed no non-conformity, therefore no ncr was initiated.A review of the labeling did not indicate any abnormalities.

Event Description

Dynamic distal locking with the target device.Drilling / screw dorsal of the nail.Locking by hand without target device.Surgical delay of 15 min.Not longer.No other consequences reported.

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6093647
• MDR Text Key: 59980354
• Report Number: 0009610622-2016-00501
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200111
• Device Lot Number: KME907440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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 Outcome(s): Other