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

Catalog Number 6260-4-090

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.

Manufacturer Narrative

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

Manufacturer Narrative

The event was confirmed by the return of the fractured device.Visual inspection: the device was returned with the threaded tip broken from the device at the first thread.The rest of the device showed normal signs of use after 5 years in the field.The root cause of the reported event was determined by a material analysis sme to be bending overload.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.

• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4874456
• MDR Text Key: 21800788
• Report Number: 0002249697-2015-02125
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 6260-4-090
• Device Lot Number: TACL506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2010
• 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
• Patient Age: 62 YR