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

Catalog Number 13200100

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 05/14/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation revealed the target device gamma3 to be the subject product. No further associated products were reported. A review of the inspection records revealed no discrepancies. The item returned was documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. As the target device had been in use for a longer time (manufactured in march 2010), we pre-suppose that the device had fulfilled its tasks in former surgeries as intended. Dimensional examination of the groove in which the c-ring was located, revealed no discrepancies. Previous complaints are known reporting a detached c-ring. In those previous cases a contribution by the design could not be excluded. Therefore a design change of the c-ring was implemented by ecn 6197/07 (see photos [5] + [6]). Internal tests confirmed the effectiveness of the new design. The new design does not prevent a c-ring detachment by 100% (i. E. In case of rough handling), but makes a detachment of the ring more difficult. The complained device was recognized as new design version; manufacturing post-dates the implementation of the design change. Since the missing c-ring could not be provided for evaluation, a physical examination of the unit was not possible. It cannot be excluded that the missing c-ring was detached prior to the surgery during the cleaning process to achieve a proper cleaning result with the target device. During detachment the ring may have been deformed which may have affected the secure fit of the ring (loosening). A missing clamping ring does not affect the targeting accuracy of the target device, because the accuracy is ensured by the nail holding screw. The clamping ring is just a feature to ease the attachment of the nail at the reception of the target device. According to the implant ifu a final check with the image intensifier is required. It was not determined why the detached ring was not identified during that procedure ¿ preventing an additional surgery. It was rather detected during post-op follow-up some days later. Review of complaint history, capa databases and risk analysis did not identify any conspicuity. The review of the risk assessment for the failure mode indicated the issue was addressed adequately. There are no open actions in place related to the reported event for the subject product. No non-conformity was identified.

Event Description

Lock ring of the target device loosened during medical procedure. The ring has to be removed during a 5 minutes surgery on (b)(6) 2017.

Manufacturer Narrative

Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.

Event Description

Lock ring of the target device loosened during medical procedure. The ring has to be removed during a 5 minutes surgery on (b)(6) 2017.

• 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: 6629322
• MDR Text Key: 251708979
• Report Number: 0009610622-2017-00185
• 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

• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 13200100
• Device Lot Number: KME902815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/09/2017 Patient Sequence Number: 1