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

Catalog Number 13200100

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that distal misdrilling occurred with the target device.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the alleged event of distal mistargeting could be confirmed.Evaluation revealed the target device as primary 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.The item returned was documented as faultless prior to distribution and as it had been in use for a longer time (approximately 9 years) we pre-suppose that this target device had fulfilled its tasks in former surgeries as intended.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.Although a real root cause could not be determined the alleged event of distal misdrilling is most likely caused due to a suboptimal intra-operative procedure.Remark: it does not have to remain out of consideration that the device had been in use for a longer period of time (more than 9 years and it was subject to periodic stress situations due to multiple applications and sterilization- and cleaning cycles.This kind of instruments should be periodically visually checked and tested for functionality.The checking of instruments prior to a surgery is requested in the instructions for use.No discrepancies were detected during risk analysis review.No new non-conformity was identified.

Event Description

It was reported that distal misdrilling occured with the target device.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3607376
• MDR Text Key: 4063765
• Report Number: 0009610622-2014-00057
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/16/2014

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 Catalogue Number: 13200100
• Device Lot Number: KP224921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 02/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2004
• 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