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

Model Number 1320-0111

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that distal screws miss-drilling occurred.Replacement was available.Surgical delay of 8min.Not longer.

Manufacturer Narrative

The reported event of alleged targeting inaccuracy could not be confirmed, since the returned device is conforming to specifications and fully functional.Evaluation revealed the target device gamma3® to be the primary device.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.Neither a proximal mistargeting nor a distal mistargeting could be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.According to event description a ¿replacement was available¿ and referring to event details the procedure was completed successfully.No indications of material, manufacturing or design related problems were found during the investigation.

Event Description

It was reported that distal screws missdrilling occurred.Replacement was available.Surgical delay of 8min.Not longer.

• 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; DE D-24232
• MDR Report Key: 9365344
• MDR Text Key: 167678712
• Report Number: 0009610622-2019-00935
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• 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
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• 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: KME910241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1