MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; INSTRUMENT

Catalog Number 2101-0200

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 06/03/2014

Event Type  malfunction  

Event Description

When the trident cup was inserted with the impactor and the impactor hited with the hammer several times.Part to hit with a hammer of handle of the impactor was broken.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot visual inspection: visual inspection was performed as part of the material analysis report (mar).Images of the device are included in the mar.The reported event was confirmed.The universal impactor/positioner striker plate (pn: 2101-0133) fractured through the threads, which remained engaged in the handle.The fractured striker plate was returned.A material analysis has been performed.The report concluded: ¿the striker plate of the handle fractured due to a fatigue failure at first, then a fast fracture from multiple overloads, which caused the device to break.The eds spectrum was consistent with (b)(4).No material or manufacturing defects were observed on the device.¿ conclusion: the striker plate of the handle fractured due to a fatigue failure at first, then a fast fracture from multiple overloads, which caused the device to break.The eds spectrum was consistent with (b)(4).No material or manufacturing defects were observed on the device.If additional information becomes available, this investigation will be reopened.

Event Description

When the trident cup was inserted with the impactor and the impactor hitted with the hammer several times.Part to hit with a hammer of handle of the impactor was broken.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3887971
• MDR Text Key: 18544076
• Report Number: 0002249697-2014-02408
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• 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: SMM7E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2012
• 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: 66 YR