MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH QUICK CONNECT HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1440-1040

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that the version handle that snaps into the broach handle broke off during a left hip surgery.Small inner pieces broke.Sales manager was informed by the surgeon that from an x-ray it was noticed that one of the ball bearings was found in the hip.Rep is not aware if the surgeon will revise the patient yet or not.

Manufacturer Narrative

Corrected data: product returned.An event regarding crack/fracture involving a quick connect handle was reported.The event was confirmed.Method & results: -device evaluation and results: the device¿s body fractured in overload.Examination of the device by the mar engineer indicated that the device fracture due to overload condition.-medical records received and evaluation: not performed as medical records were not provided.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that crack/fracture was caused by the device¿s body fracture in overload.No material or manufacturing defects were observed on the surfaces examined.

Event Description

It was reported that the version handle that snaps into the broach handle broke off during a left hip surgery.Small inner pieces broke.Sales manager was informed by the surgeon that from an x-ray it was noticed that one of the ball bearings was found in the hip.Rep is not aware if the surgeon will revise the patient yet or not.

• Brand Name: QUICK CONNECT 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6211321
• MDR Text Key: 63733329
• Report Number: 0002249697-2016-04036
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• 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: 02/23/2017

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: 1440-1040
• Device Lot Number: TAXR302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2014
• 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: 63 YR