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

Catalog Number 2101-0200

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported that he was using the introducer for a window trial during a trident thr and that as he unscrewed the introducer, a small shard of metal came away into the trial.The metal shard at no point fell into the patient and was removed from the trial immediately.

Manufacturer Narrative

An event regarding metal shards involving a cutting edge impactor was reported.The event was not confirmed.Method & results: device evaluation and results: the threads were examined by a materials engineer using 5x magnification and confirmed the debris seen in the bottom thread are from shavings from the window trial.Materials engineer confirmed there are no material deficiencies found on the threads of the impactor.Medical records received and evaluation: no patient medical records were available for review.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review could not be performed as no device specific failure has been identified.Conclusions: the issue of the reported event is unclear.The returned impactor was found to be fully functional and examination of the materials engineer confirmed there is no material deficiency found on the device.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The surgeon reported that he was using the introducer for a window trial during a trident thr and that as he unscrewed the introducer, a small shard of metal came away into the trial.The metal shard at no point fell into the patient and was removed from the trial immediately.

• 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: 5563615
• MDR Text Key: 42872206
• Report Number: 0002249697-2016-01150
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K151264
• 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: 03/16/2016

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: Health Professional
• Device Catalogue Number: 2101-0200
• Device Lot Number: B1MAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2006
• 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