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

Catalog Number 13200111

Device Problems Component Falling (1105); Fracture (1260)

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

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Tha pharmacist at the hospital, reported the following event : "during removal of a gamma nail, aring on the nail holding fractured at the end of the device, and fell into the operative field.No delay and no adverse consequences are reported by the customer.

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 2015), we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.The received target device showed significant damage / impact marks at the transition to the thread for the strike plate.The c-ring was found to be significantly bent causing its fit inside the groove of the target device being too loose leading to the reported disassociation during surgery.Dimensional examination of the groove, in which the c-ring was seated, revealed no discrepancies.Due to bend / twist of the c-ring the clamping function during the nail attachment process is no more given.However the absence of a c-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.The appearance of the c-ring indicated that it had been removed from the target device.It could not be excluded that the 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 likely got deformed / twisted, which had affected the secure fit of the ring (loosening).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 (b)(4).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.Referring to the damage patterns and based on the above observations the root cause of the reported event was not linked to a deficiency of the device, but was rather considered user related (misuse).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

Tha pharmacist at the hospital, reported the following event : "during removal of a gamma nail, a ring on the nail holding fractured at the end of the device, and fell into the operative field.No delay and no adverse consequences are reported by the customer.

• Brand Name: TARGET DEVICE GAMMA3®
• 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: 6287576
• MDR Text Key: 66355103
• Report Number: 0009610622-2017-00039
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200111
• Device Lot Number: KME907628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2015
• 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