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

Catalog Number 2101-0200

Device Problems Device Operates Differently Than Expected (2913); Compatibility Problem (2960); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Thread of the universal impactor is too long.Thread sometimes look out.

Manufacturer Narrative

An event regarding damage involving a cutting edge impactor was reported.The event was confirmed.Method & results: -device evaluation and results: 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 +.021, thereby indicating that it is out of specification.The dimension from the dowel pin to the shoulder of the handle should be.373 +/-.005 and was found to be out by -.021.The gap between the threaded stud and the handle shaft hole was measured to be out by +.025.Material analysis concluded "plastic deformation was observed on the dowel pin consistent with an overload condition.The displacement observed between the dowel pin weld and shaft handle weld; and between the threaded stud and shaft handle were measured to be approximately between 591 ¿m (0.023 inches) and 692 ¿m (0.027 inches).This indicates the threaded stud was bottomed out in the handle shaft.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: although the dimensional report confirmed two dimensions were out of specification, the mar states that the pin and weld nugget were displaced similarly to the gap between the threaded stud and the shaft handle.The dimensional report and mar both noted that the gap between the threaded stud and the handle shaft hole and the protrusion of the threaded stud was out by ~.02.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.No materials or manufacturing defects were observed on the examined device.

Event Description

Thread of the universal impactor is too long.Thread sometimes look out.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6100991
• MDR Text Key: 60293336
• Report Number: 0002249697-2016-03588
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 02/24/2017

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: 2101-0200
• Device Lot Number: 133447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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