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

Model Number 1320-0111

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 10/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "gamma nail got stuck with the nail retaining screw and could no longer be removed.Caretaker clamped a nail in a vice and was able to loosen the connection.Replacement was available (31251200s lot k0237ec) and procedure was completed manually.Surgical delay of 2 hours not longer.Patient had to get foreign blood due to the duration of the surgery".

Manufacturer Narrative

The reported event could not be confirmed since the alleged failure could not be reproduced.However, the target device was found to be damaged and must not be used in further surgeries.The device inspection revealed the following: the received target device was found to be damaged around the entry point in the head region.The manner of damage indicates toward a forceful attempt to dismount the nail holding screw and the nail from the target device.This damage happened after the nail got stuck and hence didn¿t contribute to the current event.However, no sign of obvious damage was found at the distal most end if the target device, from where the nail gets attached.A pre-surgical functional test was performed with the returned nail holding screw, target device and a sample nail.The nail holding screw could be assembled with the target device and could be locked with the sample nail without any difficulty.Thus, the reported failure could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the alleged failure could not be reproduced, the failure could not be confirmed and the real root cause could not be determined, but since a product deficiency was not identified, the issue is deemed to be user related.Upon reviewing similar cases in the past, the most likely reason for such jamming of nail with the target device is due to a misaligned assembly of the nail with the nail holding screw, which leads to overlapping of the threads and a subsequent jamming.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "gamma naill got stuck with the nail retaining screw and could no longer be removed.Caretaker clamped a nail in a vice and was able to loosen the connection.Replacement was available (31251200s lot k0237ec) and procedure was completed manually.Surgical delay of 2 hours not longer.Patient had to get foreign blood due to the duration of the surgery".

• 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: 10757442
• MDR Text Key: 213866325
• Report Number: 0009610622-2020-00617
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: KME909377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR