MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIDENT HEX DRIVER FOR CURVED CUP IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number I-H1385HEX0

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not available.

Event Description

Company rep reported, while implanting a trident cup, the cup impactor locked on the cup.The doctor could not release the impactor from the cup.The hex driver "stripped" and could not loosen the nut holding the cup.After 30 minutes of trying, the cup was removed and a new cup implanted with a different style impactor.

Manufacturer Narrative

An event regarding a disassembly issue of a specialty driver shaft was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Company rep reported, while implanting a trident cup, the cup impactor locked on the cup.The doctor could not release the impactor from the cup.The hex driver "stripped" and could not loosen the nut holding the cup.After 30 minutes of trying, the cup was removed and a new cup implanted with a different style impactor.

Manufacturer Narrative

Product available to stryker.An event regarding alleged damage of a specialty driver shaft was reported.The event was confirmed.Method & results: device evaluation and results: a review of the device by the materials engineer indicated "damage observed on tip of driver, consistent with contact against a hard object and in-service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event has been confirmed on the basis of review of the device by the materials engineer indicating "damage observed on tip of driver, consistent with contact against a hard object and in-service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." if additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Company rep reported, while implanting a trident cup, the cup impactor locked on the cup.The doctor could not release the impactor from the cup.The hex driver "stripped" and could not loosen the nut holding the cup.After 30 minutes of trying, the cup was removed and a new cup implanted with a different style impactor.

• Brand Name: SPECIALTY TRIDENT HEX DRIVER FOR CURVED CUP IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6680474
• MDR Text Key: 78802638
• Report Number: 0002249697-2017-02092
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: I-H1385HEX0
• Device Lot Number: F11M11390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 08/23/2017; 03/21/2018
• Supplement Dates FDA Received: 09/18/2017; 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 73