MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH QUICK-CONNECT HANDLE (2/PK); PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 8000-0000

Device Problems Material Deformation (2976); Material Distortion (2977); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Items were hit with a mallet and bent/stuck together.

Manufacturer Narrative

An event regarding damage involving a scorpio handle was reported.The event was confirmed.Device evaluation and results: the returned handle is in used condition; the body of the device is scratched and marked consistent with repeated use.The tip of the scorpio handle was deformed.Examination of the returned device with material analysis engineer noted that tip of the body of the device was deformed, abrasion damage was also observed at this tip.Medical records received and evaluation: not performed because the reported event is not related to clinical factors.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: a visual inspection of the returned device shows the body of the device is scratched and marked consistent with repeated use.The tip of the scorpio handle was deformed.Examination of the returned device with material analysis engineer noted that tip of the body of the device was deformed, abrasion damage was also observed at this tip.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Items were hit with a mallet and bent/stuck together.

• Brand Name: QUICK-CONNECT HANDLE (2/PK)
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 6775319
• MDR Text Key: 82088573
• Report Number: 0002249697-2017-02415
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000-0000
• Device Lot Number: RD6W050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other