MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN BROACH; HIP INSTRUMENT

Catalog Number UNK_REC

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Rep reported patient had total left hip surgery.Faulty instrument during surgery, no consequences to patient.When impacting, the broach would pop off handle.

Manufacturer Narrative

Product not returned.An event regarding alleged non-functional device involving an unknown rasp was reported.The reported device (unknown broach) was not returned.The reported event stated alleged "non-functional" unknown broach.This was confirmed based on the return of the reported device rasp handle.Based on the provided information, the reported product, unknown broach in this investigation did not contribute to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Rep reported patient had total left hip surgery.Faulty instrument during surgery, no consequences to patient.When impacting, the broach would pop off handle.

• Brand Name: UNKNOWN BROACH
• Type of Device: HIP 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6272902
• MDR Text Key: 65916134
• Report Number: 0002249697-2017-00318
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/02/2017

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: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• 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: 70 YR