MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2101-0200

Device Problems Break (1069); Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problems Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

A trident cup was loaded onto a trident impactor and impaction was attempted.Upon failing to seat the cup the surgeon removed it and noticed that the impactor thread was too long and had protruded through the cup.The scrub nurse was junior and inexperienced, and did not notice herself.

Manufacturer Narrative

Corrected data: adverse event/product problem; outcomes attributed to ae; type of reportable event.An event regarding size/fit issue involving a trident impactor was reported.The event was confirmed.Dimensional inspection confirmed that the threaded stud protrusion past the impaction shoulder feature of the handle assembly was not within specification.The threaded stud should protrude.130, ±.005.The protrusion was measured and found to be out by +.110, thereby indicating that it is out of specification.The length of the threaded stud should be.875 ±.005.The length was measured and found to be within specification at.8755.Also, tech services indicated when they drilled the shaft at the dowel pin location of.373, the pin was not there.The actual pin location was approximately at.273.Material analysis concluded, "the cup impactor fractured in overload.The distance between the bottom of the shaft opening and the threaded stud was reported to be 0.002 in.Based on visual examination of the shaft handle and threaded stud, a press fit condition was achieved.The dowel pin was damaged; a fracture surface analysis and original location evaluation could not be performed.Eds was performed on the shaft and found to be consistent with 17-4 ph stainless steel.The shaft hardness of hrc 44 meets drawing requirements.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The reported event was confirmed as the returned instrument was measured and found the protrusion of the threaded stud to be out of specification.The mar concluded that the cup impactor fractured in overload.Although the dimensional report confirmed the protrusion was out of specification, the mar noted that the stud was seated at the bottom of the shaft.This provides evidence that the device was manufactured and assembled correctly initially and that during use the pullout of the threaded stud from the hole occurred.Based on visual examination, a partial press fit condition was achieved between the shaft handle and threaded stud.No material or manufacturing defects were observed on the surfaces examined.

Event Description

A trident cup was loaded onto a trident impactor and impaction was attempted.Upon failing to seat the cup the surgeon removed it and noticed that the impactor thread was too long and had protruded through the cup.The scrub nurse was junior and inexperienced, and did not notice herself.Update: surgeon noticed the cup wasn't seated properly, removed cup impactor with the cup and noticed the acetabulum had a small puncture defect.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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: 6935376
• MDR Text Key: 89864212
• Report Number: 0002249697-2017-02955
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0200
• Device Lot Number: 135315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• 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: 56 YR
• Patient Weight: 64