MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13205320

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

The nurse reported to our sales rep that he was observing a surgery procedure.During this procedure, he observed that the surgeon had problems with the distal target device.While using the device, the fixation broke and a crack was noticed.The surgeon went ahead with freehand targeting to complete the surgery successfully.Also, the procedure has been performed as specified.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported issue was confirmed.The evaluation revealed the distal target device (dtd) to be the primary product.No associated products were reported.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.3 years we pre-suppose that it had fulfilled its tasks in former surgeries as intended.The shifted spring washers contacted the peek material during clamping and got jammed; the clamp mechanism was blocked.These blocking created high pressure forces to the peek material of the clamping mechanism and the material cracked.Finally the cracked peek material broke during locking the dtd to a target device.The broken clamping mechanism is design related.A change request was initiated to address shifted spring washers; the washers were replaced by an elastic spring element (non-metallic).The design change became effective in (b)(6) 2014 (complained dtd was manufactured prior to design change).Furthermore a change request was initiated to improve the curvatures of the peek material.The radius was changed from 1mm to 2mm.The change became effective in (b)(6) 2010 (complained dtd was manufactured post to design change).A capa was initiated to address rough surfaces around the curvatures (manufacturing related).A tool optimizing was performed at the supplier in (b)(6) 2011 (complained dtd was manufactured prior to capa).No discrepancies were detected during risk analysis review.No non-conformity identified; actions are in place.

Event Description

The nurse reported to our sales rep that he was observing a surgery procedure.During this procedure he observed that the surgeon had problems with the distal target device.While using the device the fixation broke and a crack was noticed.The surgeon went ahead with freehand targeting to complete the surgery successfully.Also, the procedure has been performed as specified.

• Brand Name: DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0
• 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 mincieli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3649447
• MDR Text Key: 17611062
• Report Number: 0009610622-2014-00101
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13205320
• Device Lot Number: KP324833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2011
• 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