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

Catalog Number 13200100

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/10/2015

Event Type  malfunction  

Event Description

It is reported by male nurse of the hospital, that there was a missdrilling during the distal locking.Target device got a crack.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation revealed the target device as primary product.Concomitant products were not reported.Appearance of item and inspection records identified the target device returned being of old 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.The function of the target device returned was still given although significant impacts and cracks as well as a small gap causing slight wobbling between targeting arm and nail adapter were found in the cfr-material.The alleged distal targeting issue could not be reproduced.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 alleged event(s) were mainly based in the intra-operative procedure.The target device returned was documented as faultless prior to distribution and as it had been in use for a longer time (more than 9 years) we pre-suppose that this target device had fulfilled its tasks in former surgeries as intended.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 (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.Collateral findings: it could be assumed that the cracks found are the result of internal material stresses enforced by multiple sterilization- and cleaning processes over the years of being in use.Internal lab test report (b)(4) revealed that deviation due to cracks does not lead to increased damages at the nail.This indicates that the interlaminar crack do not influence the targeting performance critically.Referring to compiled hat (b)(4) it was concluded that no action in the market should be performed.The brochure instructions for cleaning, sterilization, inspection and maintenance (b)(4) shows several examples of damages and recommends removing such damaged products.With engineering change notice ecn (b)(4) the material of the cfr-arm has already been changed in order to improve stiffness and avoid cracking.Lab test (b)(4) had verified the suitability of the new material.The significant impacts found at the metal nail adapter and at the lower curved part of the target device are due to hammering onto the device which is regarded as rough handling and thus user related.The above noticed significant impacts, cracks and gap are clearly visible and should have been noticed already during required checking of the instruments which is required by the ifu prior surgery.

Event Description

It is reported by male nurse of the hospital, that there was a missdrilling during the distal locking.Target device got a crack.

• 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-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4649349
• MDR Text Key: 15914050
• Report Number: 0009610622-2015-00141
• Device Sequence Number: 1
• Product Code: HSB
• 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: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• 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: KP236075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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