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

Model Number 1320-0111

Device Problem Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they have had gamma failures (raised separately) and they are not sure if the jig or sleeve are at issue in any of the failures as they do not know which case the jig / sleeve were used in.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.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.Although a root cause could not be determined the alleged event is most likely caused due to a sub-optimal intraoperative procedure and has to be classified as user-customer-user error.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check performed, which is required per ifu, it was concluded that the event was mainly based in the medical procedure.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused by (but not limited to): loosening of the nail holding bolt during insertion of the nail repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended.Not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve).No use of drill with centre tip / unfavourable bone contour drilling without drill guiding sleeve.Using blunt or damaged drill.High forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.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.

Event Description

The customer reported that they have had gamma failures (raised separately) and they are not sure if the jig or sleeve are at issue in any of the failures as they do not know which case the jig / sleeve were used in.

• 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
• MDR Report Key: 10351253
• MDR Text Key: 203170552
• Report Number: 0009610622-2020-00421
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: KME909483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1