MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; INSTRUMENT

Catalog Number 13200100

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

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

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Gamma 3 target device failed.Drill placed in wrong position.

Manufacturer Narrative

The evaluation revealed the target device to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The item returned was documented as faultless prior to distribution.As the device had been in use for approx.6 years we pre-suppose that it had fulfilled its tasks in former surgeries as intended.During investigation no material, design or manufacturing related issues were found.A functional test with sample nails and sample instruments showed that all proximal (120°, 125°, 130°) and all distal (static, dynamic) nail holes were passed by the drills without nail contact; the reported wrong drill position was not reproducible.The found damages on the target device are the result of several impacts with a hammer.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited to, if e.G.The following instructions are not carried out properly: 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.The ifu and operative technique includes several warnings and precautions regarding misdrilling; the operative technique was updated regarding misdrilling in 2008.Because no manufacturer related issue was found the reported event is attributed to a user error.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.

Event Description

Gamma 3 target device failed.Drill placed in wrong position.

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• Type of Device: INSTRUMENT
• 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: 6239277
• MDR Text Key: 64761455
• Report Number: 0009610622-2017-00003
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: KME902826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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