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

Catalog Number 1601-1100

Device Problem Device Inoperable (1663)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Broach handle stopped working.

Manufacturer Narrative

An event regarding an alleged malfunctioning of a securfit advanced broach handle was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.The device showed scratches, burrs and cuts throughout but was otherwise clean and in good condition.Examination of the returned device with material analysis engineer indicated that no mar is required.Fracture mode is consistent with a previous completed mar.It concluded that hook fractured due to an overload condition.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: there has been two other events for the lot referenced.Visual analysis showed that the device was returned in used condition.Examination of the returned device with material analysis engineer indicated that the fracture mode is consistent with previous completed mar.Therefore, it is concluded that the alleged malfunctioning of the device was the result of a fracture due to overload conditions.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Broach handle stopped working.

• Brand Name: SECUR-FIT ADVANCED BROACH HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5930208
• MDR Text Key: 54548002
• Report Number: 0002249697-2016-02862
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: B6WAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2012
• 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: 40 YR
• Patient Weight: 129