MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200100

Device Problem Mechanics Altered (2984)

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

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported by the nurse of the hospital, that a distal locking is not possible.Drill running behind the nail.Free hand locking.The customer has upon receipt of the target sleeve no longer misdrillings reported and does not want to exchange the target device.Sales rep.Also discussed with the chief physician because of this current case, to switch the nails of 200 mm to 180 mm in order to prevent further incorrect drilling in this area.The change takes place later this week.

Manufacturer Narrative

The evaluation revealed the target device to be the primary product; the provided sleeve and knob were found fully functional.An inspection and a review of the dhr for the target device were not possible because the target device and the lot code were not provided.The customer reported that the target device functioned like specified with a new speedlock sleeve; the complained misdrilling was no longer given; the customer confirmed the target device as fully functional.Because the target device was not returned and the provided sleeve and knob were found fully functional the reported misdrilling was not reproducible and could not be confirmed.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.: ¿ no fully tightened nail holding screw, ¿ bending forces to the drill / drill sleeve during drilling, ¿ drill sleeve has no contact to the bone surface, ¿ usage of worn drills.Regarding misdrilling the operative technique has already been modified by ecn (b)(4).Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure.The development of a new targeting sleeve with integrated clamping function (combination of sleeve and knob) is completed and resulted in a new device (gamma3 speedlock sleeve).Starting in july 2009, the speedlock sleeve has been available to all markets.The former targeting sleeve and the knob are phased out.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.Device was not returned.

Event Description

It is reported by the nurse of the hospital, that a distal locking is not possible.Drill running behind the nail.Free hand locking.The customer has upon receipt of the target sleeve no longer missdrillings reported and does not want to exchange the target device.Sales rep.Also discussed with the chief physician because of this current case, to switch the nails of 200 mm to 180 mm in order to prevent further incorrect drilling in this area.The change takes place later this week.

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• 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: 5628235
• MDR Text Key: 44778609
• Report Number: 0009610622-2016-00230
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200100
• Device Lot Number: KHI1070668
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• 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
• Patient Outcome(s): Other