MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT ADVANCED BROACH HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1601-1100

Device Problems Break (1069); Fracture (1260); Device Inoperable (1663); Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

It was reported that the broach handle stopped working.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was confirmed.Examination from material analysis stated that the retention hook for the broach handle failed in multiple event overload 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

It was reported that the broach handle stopped working.

• Brand Name: SECUR-FIT ADVANCED BROACH HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 4738482
• MDR Text Key: 5703558
• Report Number: 0002249697-2015-01392
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1601-1100
• Device Lot Number: B4LAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2009
• 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: 65 YR
• Patient Weight: 94