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

Model Number 1320-0111

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.Device disposition is unknown.

Event Description

The customer reported that the ring of the gamma3 bracket came loose and fell into the wound.

Manufacturer Narrative

The reported event could be confirmed based on the pictures received from the customer.The device identification was not possible since the affected device was not returned but based on the pictures shared by the customer, a visual inspection was performed: the images shared reveal that the gap in the ring had widened.The change in geometry of the ring possibly affected its grip on the targeting device, hence it became loose.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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].The c-ring [clamping ring] is a feature to ease nail assembly ¿ but the function is still given without the c-ring.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 ¿ the c-ring design was modified.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.Since the device had been in use for about 10 years, a natural wear and tear of the ring geometry is also deemed plausible.If the device is returned or any additional information is provided, the investigation will be reassessed.

Event Description

The customer reported that the ring of the gamma3 bracket came loose and fell into the wound.

• 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12584325
• MDR Text Key: 274991166
• Report Number: 0009610622-2021-00733
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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