MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 3.2 X 450MM K-WIRE; INSTRUMENT

Catalog Number UNK_KIE

Device Problems Device Slipped (1584); Failure to Advance (2524); Malposition of Device (2616); Material Deformation (2976)

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

Event Date 05/11/2019

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.

Event Description

It was reported that, while placing the lag screw for a gamma3 nail, the guide piece t-handle attached to shanz pin did not allow guidewire to pass through, causing guidewire to slip further through the bone and into the pelvis.Ap view revealed guidewire had penetrated the pelvis 15 cm.After removal of the lag screw t-handle it was observed that the tip of the inner cannula was deformed, preventing the guidewire from entering the cannulation, causing the advancement of the guidewire into the pelvic space.Additional surgical procedure occurred as a result; opening the patient's abdomen to check for injury, which lasted for 3 hours and 23 minutes.No guidewire injury to the pelvis was noted.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.The operative technique mentioned that in case a deflection of the k-wire is observed, it is strongly recommended to remove the k-wire and replace it by a new one.If the stepdrill does not pass through the lag screw hole with ease, check by image intensifier whether the k-wire is deflected or not.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application errors; person makes a mistake, slip during surgery.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that, while placing the lag screw for a gamma3 nail, the guide piece t-handle attached to shanz pin did not allow guidewire to pass through, causing guidewire to slip further through the bone and into the pelvis.Ap view revealed guidewire had penetrated the pelvis 15 cm.After removal of the lag screw t-handle it was observed that the tip of the inner cannula was deformed, preventing the guidewire from entering the cannulation, causing the advancement of the guidewire into the pelvic space.Additional surgical procedure occurred as a result; opening the patient's abdomen to check for injury, which lasted for 3 hours and 23 minutes.No guidewire injury to the pelvis was noted.

• Brand Name: UNKNOWN 3.2 X 450MM K-WIRE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8667946
• MDR Text Key: 146968659
• Report Number: 0009610622-2019-00471
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR