MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 56MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 2208-2056

Device Problems Material Deformation (2976); Material Distortion (2977); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that while performing a primary right total hip arthroplasty procedure, the threads in the liner trial stripped and the trial could not be removed using the inserter.A surgical delay of 5-10 minutes occurred in prying the trial out.Later in the case, the tip of a screwdriver shaft bent or flexed.Procuring another screwdriver caused an additional 3 minute delay in surgery.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

An event regarding stripped threads (thread damage) involving a trident trial was reported.The event was confirmed.Conclusions: the reported event of threads in the liner trial stripped was confirmed.Based on a visual inspection the threads of the device were worn.An evaluation from a material analysis engineer indicated, damage observed on threads of device consistent with cross threading and off-axis loading.In-service use damage also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.

Event Description

It was reported that while performing a primary right total hip arthroplasty procedure, the threads in the liner trial stripped and the trial could not be removed using the inserter.A surgical delay of 5-10 minutes occurred in prying the trial out.Later in the case, the tip of a screwdriver shaft bent or flexed.Procuring another screwdriver caused an additional 3 minute delay in surgery.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: TRIDENT ACET WINDOW TRIAL 56MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7174616
• MDR Text Key: 96712574
• Report Number: 0002249697-2018-00076
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2208-2056
• Device Lot Number: 90085901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR