MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM -3MM V40 TRIAL HEAD; INSTRUMENT

Catalog Number 6264-8-026R

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

At the bha surgery, after the final trial reduction with v40 head trial, when the trial head with outer head was took off, the doctor confirmed the trial head was broken.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding a fractured trial head involving a partnership trial head was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection confirmed the reported event.Material analysis was performed on the reported device, which concluded the proximal end of the trial fractured in overload.In addition, no material or manufacturing defects were observed.Medical records received and evaluation: not performed as medical records were not provided for evaluation.Device history review: review of device history records indicates the lot was manufactured and accepted into final stock free of discrepancies.Complaint history review: there has been (b)(4) other event for the lot referenced.Conclusions: the investigation concluded that the reported fracture was caused by multiple overload conditions.No manufacturing defects were observed.

Event Description

At the bha surgery, after the final trial reduction with v40 head trial, when the trial head with outer head was took off, the doctor confirmed the trial head was broken.

• Brand Name: 26MM -3MM V40 TRIAL HEAD
• Type of Device: INSTRUMENT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3781305
• MDR Text Key: 14880081
• Report Number: 0002249697-2014-01612
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

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: 6264-8-026R
• Device Lot Number: SS105101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2010
• 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