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

Catalog Number 2101-0200

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975); Mechanics Altered (2984)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported by the nurse of the hospital, that the thread of the impactor is too long.The thread sticks out from the pan.The pan could not be fixed and they had to mill once again.The unwrapped implants has to be discarded.The next size could be taken with another impactor.

Manufacturer Narrative

An event regarding excessive thread length involving a universal impactor/positioner 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 device was out of specification.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: the investigation determined the root cause of the reported event to be supplier manufacturing management.

Event Description

It is reported by the nurse of the hospital, that the thread of the impactor is too long.The thread sticks out from the pan.The pan could not be fixed and they had to mill once again.The unwrapped implants has to be discarded.The next size could be taken with another impactor.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5675774
• MDR Text Key: 45786153
• Report Number: 0002249697-2016-01677
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K151264
• 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: 04/26/2016

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: No Information
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 2101-0200
• Device Lot Number: SMM9E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2016
• Initial Date FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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