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

Catalog Number 13200100

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Snap ring of the target arm remain in the patient.

Manufacturer Narrative

Product inquiry states the target device gamma3 to be the subject product.A review of the device history records revealed no discrepancies.No further associated products were reported.The item returned was documented as faultless prior to distribution.The reported event ¿snap ring of the target arm remain in the patient.¿ could be confirmed based on the x-ray image provided.The c-ring itself was not returned for a physical evaluation.A detailed visual inspection of the groove at the reception for the nail, intended position of the c-ring, revealed material deformation at the rim of the circumferential groove.Due to missing check of the c-ring, it was not recognized that it was deformed or damaged.The c-ring (clamping ring) is a feature to ease nail assembly ¿ but the function is still given without the c-ring.Since the missing c-ring was not made available for evaluation, a physical examination of the unit was impossible.It cannot be excluded that the missing c-ring was detached prior to the surgery during the re-processing.During detachment the ring may have been deformed and / or may have been attached in unintended mode which may have affected the secure fit of the c-ring (loosening).Previous complaints are known reporting a detached c-ring.In these previous cases a contribution by the design could not be excluded.Therefore a design change was performed, ecn# 6197/07 ¿ the c-ring design was changed.Internal tests confirmed the effectiveness of the new design: the new design does not prevent a c-ring detachment every time (i.E.In case of rough handling), but make a detachment more difficult.However, based on the information given a real root cause of the reported event cannot be determined.Finally, it lies in the responsibility of the treating surgeon to remove or to leave the detached c-ring in the patient body.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 actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

Snap ring of the target arm remain in the patient.

Manufacturer Narrative

The reported event ¿snap ring of the target arm remain in the patient.¿ could be confirmed based on the x-ray image provided.As the product in question was not available for evaluation a physical examination was not possible.Due to unknown lot code tracing as well as review of the inspection records of the reported product was not possible.However, based on the information given a real root cause of the reported event cannot be determined.Review of complaint history, capa databases and risk analysis did not identify any deviations.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No nonconformity was identified.The file will be closed formally and in case the item and / or substantive information will become available in future we reserve the right to reopen the investigation and to change the root cause.Device is not available to stryker.

Event Description

Snap ring of the target arm remain in the patient.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6896000
• MDR Text Key: 87446082
• Report Number: 0009610622-2017-00298
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200100
• Device Lot Number: KME904008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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