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

Catalog Number 2107-1015

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

The other devices listed in this report: cat.No.: 2208-4062, tritanium acetabular trial.Lot code: unknown.Cat.No.: 2107-1015, universal driver shaft, lot code: unknown.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.

Event Description

A report to a company representative was in regard to the following event: during a revision surgery, the surgeon was unable to fix the acetabulum tritanium due to missing elements in the ancillary.The medical staff had to implant another device.This event caused intraoperative difficulties and lengthened the time of the intervention.

Manufacturer Narrative

An event regarding other (a screw driver was missing in the kit) involving a trident 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: no medical records or x-rays were made available for evaluation.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: it was reported that the surgeon could not fix the acetabulum tritanium since screwdriver was missing in the kit which caused 20 minutes delay.The event could not be confirmed nor the root cause could be determined due to the minimal information received.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

A report to a company representative was in regard to the following event: during a revision surgery, the surgeon was unable to fix the acetabulum tritanium due to missing elements in the ancillary.The medical staff had to implant another device.This event caused intraoperative difficulties and lengthened the time of the intervention.Event update: there is a 20 minute surgical delay and main complaint was a screwdriver was missing in the kit.No issues with the implant.

• Brand Name: UNIVERSAL 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; 200 suhong road, sip; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6651164
• MDR Text Key: 77927909
• Report Number: 0002249697-2017-01924
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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: 2107-1015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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