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

Catalog Number 13200111

Device Problem Component Falling (1105)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The pharmacist at the hospital, reported the following event : " during a surgery, when implanting a gamma nail, the ring of the target device fell.The surgeon could retrieve it.A second gamma nail ancillary has been opened.

Manufacturer Narrative

Referring to the product inquiry the target device gamma3® is the only reported device and thus considered the primary product.Since the review of the inspection records revealed no discrepancies, we exclude deviations in manufacturing.The item was documented as faultless prior to distribution.As the target device had been in use for a longer time (manufactured in november 2013) we pre-suppose that it had fulfilled its tasks in former surgeries as intended without problems reported.Dimensional examination of the groove in which the c-ring is located, revealed no discrepancies.Apart from the bend / twist the dimensions of the c-ring were found to be within specified tolerances, as well.The target device received shows traces of frequent use.Furthermore, the device shows significant damage / impact marks at the transition to the thread for the strike plate.Upon receipt the seating of the c-ring in the groove at the reception for the nail was incorrect (turned by 180 degrees).In addition, the c-ring is bent and the fit inside the groove is too loose.Thus, proper function is no longer given.During the investigation the seating of the c-ring was corrected, but even if the seating of the c-ring was correct the bend / twist of the ring prevented proper attachment of the nail.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.Appearance of the c-ring indicates that it has been removed from the target device, whereas it cannot 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 has been deformed / twisted which has 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 ecn # (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 is not linked to a deficiency of the device, but is 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

The pharmacist at the hospital, reported the following event: during a surgery, when implanting a gamma nail, the ring of the target device fell.The surgeon could retrieve it.A second gamma nail ancillary has been opened.

• 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: 5853127
• MDR Text Key: 52418799
• Report Number: 0009610622-2016-00390
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K1123401
• 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: 07/12/2016

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: 13200111
• Device Lot Number: KME905780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2013
• 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