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 Operates Differently Than Expected (2913)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Reported event: an event regarding an alleged "non-functional" involving a securfit advanced broach handle was reported.The event was not confirmed.Method & results: device evaluation and results: the subject device was returned and showed signs of use.No significant damages observed on the device.Functional testing was performed for the returned broach handle with the compatible broach from finished goods, catalog# 1601-1012a and lot# mkjyw9.The returned broach handle and the broach were assembled by inserting the alignment tab on the distal end of the broach handle onto the broach.An audible click was heard indicating the broach was securely engaged.Using a mallet, the returned broach handle and the broach was impacted multiple times and the broach stayed fully attached.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 no other events for the lot referenced.Conclusion: the event was not confirmed.Visual analysis showed that the device was returned in used condition.However, no significant damages were observed on the device.Functional testing was performed for the returned broach handle with a compatible broach from finished goods and the devices assembled successfully.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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6689676
• MDR Text Key: 79177057
• Report Number: 0002249697-2017-02110
• 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
• Report Date: 07/06/2017

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: 1601-1100
• Device Lot Number: B2VFJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2010
• 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: 51 YR
• Patient Weight: 58