MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM MANCHON EXPANS; INSTRUMENT

Catalog Number 1235-4-525

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that during a primary surgery, the instrument broke into two pieces upon inserting the adm cup.The pieces were removed without incident and the surgery was completed successfully.

Event Description

It was reported that during a primary surgery, the instrument broke into two pieces upon inserting the adm cup.The pieces were removed without incident and the surgery was completed successfully.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding fracture involving an adm expandable coupler was reported.The event was not confirmed.Device evaluation not performed as the device was not returned for evaluation.Device history review could not be performed as the lot details are unknown.The exact root cause could not be determined, based on the information provided.

• Brand Name: RESTORATION ADM MANCHON EXPANS
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3667419
• MDR Text Key: 4345417
• Report Number: 0002249697-2014-00691
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2014

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: 1235-4-525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR