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

Catalog Number 2107-1015

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Tip of screwdriver catalog # 2107-1015 broke off inside of the screw head upon attempted removal of a bone screw.The tip was unable to be removed from the screw head and was left in place.

Manufacturer Narrative

An event regarding crack/fracture involving a universal driver shaft was reported.The event was confirmed.Method and results: device evaluation and results: the tip of the universal driver shaft was fractured off.A discussion with the mar group, concluded based on a visual inspection, of the universal driver shaft found the fracture to be from torsional overload.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were provided.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been 1 other event for this lot.Conclusions: the investigation concluded that the fractured tip of the universal driver shaft was caused by torsional overload.No material or manufacturing defects were observed on the surfaces examined.

Event Description

Tip of screwdriver catalog # 2107-1015 broke off inside of the screw head upon attempted removal of a bone screw.The tip was unable to be removed from the screw head and was left in place.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5842046
• MDR Text Key: 52119433
• Report Number: 0002249697-2016-02501
• 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
• Report Date: 07/06/2016

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: F10M87331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2015
• 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: 62 YR
• Patient Weight: 67