MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 36MM +10MM TRIAL HEAD; INSTRUMENT

Catalog Number 6264-8-336R

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

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

Event Date 01/29/2014

Event Type  malfunction  

Event Description

The neck of the v40 trial head was broken when it was performed reduction.

Manufacturer Narrative

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

Manufacturer Narrative

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 have been no other events reported for the reported manufacturing lot visual inspection: inspection was performed as part of mar dated 18-feb-2014.A material analysis was performed concluding the following: there was damage to the o-ring and the teflon coating of the o-ring at the fracture location.The head trial broke from overload conditions with the fracture progressing from the inside diameter of the machined tapered surface of the trial head outward most likely from contact with the trunnion of the stem.The investigation determined the likely root cause of the broken trial head was from overload conditions.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

The neck of the v40 trial head was broken when it was performed reduction.

• Brand Name: 36MM +10MM TRIAL HEAD
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER SUZHIOU (MDR); no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou NJ 21502 ; CH 21502
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3638803
• MDR Text Key: 3985792
• Report Number: 0002249697-2014-00472
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-8-336R
• Device Lot Number: SS106517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2010
• 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