MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2107-1014

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2016

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.

Event Description

Attempted to tight a plug by the stryker omni flex drive shaft after implanted the trident psl non-holl cup for tha treatment, it was bookend the tip of the stryker omni flex drive.The broken tip was removed out of patient body and continuing the procedure.

Manufacturer Narrative

An event regarding a fractured hexalobular screwdriver tip from a trident driver shaft was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned device shows hexalobular tip of driver shaft was fractured.The fractured piece was included with the returned driver shaft.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.Material analysis is not performed as this falls under the scope of a capa.Medical records received and evaluation: a review of medical records was not performed as none were provided.No further information was requested as there is no indication the failure was related to patient factors.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 7 other events for the lot referenced.Conclusions: the reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of driver shaft was fractured.The fractured piece was included with the returned driver shaft.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.Material analysis is not performed as this falls under the scope of a capa.

Event Description

Attempted to tight a plug by the stryker omni flex drive shaft after implanted the trident psl non-holl cup for tha treatment, it was bookend the tip of the stryker omni flex drive.The broken tip was removed out of patient body and continuing the procedure.

• Brand Name: STRAIGHT DRIVER SHAFT
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6158615
• MDR Text Key: 62379248
• Report Number: 0002249697-2016-03876
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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
• Report Date: 02/13/2017

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: 2107-1014
• Device Lot Number: FZK371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2005
• 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