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

Catalog Number 2107-1015

Device Problems Degraded (1153); Difficult to Insert (1316); Material Integrity Problem (2978); Naturally Worn (2988)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During primary hip surgery, the screw could not be inserted due to the wear of the driver tip.

Manufacturer Narrative

An event regarding a wear involving a trident universal driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: 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 no medical records were received for review with a clinical consultant.-device history review: review of the device history records was performed and the product was released with no reported discrepancies.-complaint history review: based on the device identification the complaint databases were reviewed for similar reported events regarding universal driver shaft tip wear and there have been 1 similar previous reported events for this lot id.Conclusions: the reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of screwdriver 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.The capa investigation found that the failure mode is observed when the driver is over torqued, the driver tip wears excessively due to repeated use of the driver, or when the driver tip is angulated extremely within the screw head during use.

Event Description

During primary hip surgery, the screw could not be inserted due to the wear of the driver tip.

• 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; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6211314
• MDR Text Key: 63708985
• Report Number: 0002249697-2016-04035
• 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: 02/24/2017

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: F11C97761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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