MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; INSTRUMENT

Catalog Number 6260-4-090

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Extractor tip broke off inside stem.

Manufacturer Narrative

An event regarding fracture involving a mcreynolds adapter was reported.The event was confirmed.Method & results: -device evaluation and results: thread damage was observed on the adapter tip as well as on the edges of the fractured portion stuck in the stem.-medical records received and evaluation: not performed as there is no indication the event is related to patient factors.-device history review: review of the device history records indicates all devices accepted into final stock met specifications.-complaint history review: there have been 2 other events for this lot.Conclusions: the investigation concluded that the device fractured in overload.Damage to the threads was observed.The exact origin of the damage could not be determined.It is possible the thread damage was hindering the smooth threading of the adapter in the distal stem.This could have led to seizing of the adapter in the distal stem and subsequent fracture of the device.

Event Description

Extractor tip broke off inside stem.

• Brand Name: MCREYNOLDS IMPACTOR ADAPTER
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5062454
• MDR Text Key: 25818857
• Report Number: 0002249697-2015-02928
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122853
• 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: 12/27/2016

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 Expiration Date: 09/15/2015
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TACJ50A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2008
• 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: 81 YR