MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERIARTICULAR LOCKING PLATE SCREW

Catalog Number 47235905045

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

It is reported a foreign material was present in the groove of the screw.Al alternate screw was used.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No description of the foreign material was provided, or is available.Pictures of the foreign material were requested, but were also unavailable.Zimmer biomet (b)(4) stated that upon receipt at their facility, the foreign material did not appear to be present.The screw was received for evaluation along with its packaging, and the screw was autoclaved upon receipt.Visual inspection of the returned screw after autoclaving noted white material on the inner diameter of the screw between 2 or 3 screw threads which is barely visible without magnification.The composition of the residue was noted as consistent with sanitizing solution.It has also been noted that a red/brown stain appears on the inner surface of the tyvek lid.Packaging cosmetic criteria was reviewed, finding the lid as received would be acceptable in the manufacturing environment, although it cannot be determined when the stain occurred.Review of the device history record did not find any deviations or anomalies.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combination.Since there is no information on the foreign material on the screw, a definite root cause cannot be determined with the information provided.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER PERIARTICULAR LOCKING PLATE SCREW
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4846954
• MDR Text Key: 5931279
• Report Number: 1822565-2015-00911
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 47235905045
• Device Lot Number: 62421745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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