MAUDE Adverse Event Report: ZIMMER, INC. M/L TAPER RASP LONG POST; HIP INSTRUMENT

Model Number N/A

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been returned to zimmer biomet and the investigation is currently in process.Once the investigation has been completed, a follow up report will be submitted.

Event Description

It was reported that after broaching, the stem sat proud.The surgeon indicated the broach was dull and a larger size broach was used to complete the procedure.There was no reported patient injury or significant delay as a result of the event.Attempts have been made and no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event could not be verified.Visual inspection of the devices shows the cutting edges are dull and damaged.All returned rasps were evaluated using their respective overlay that measures size specifications except for some cutting edges fell under the tolerance zone due to damage and/or dullness.Hardness readings measured conforming to print specification.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M/L TAPER RASP LONG POST
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6553942
• MDR Text Key: 74741783
• Report Number: 0001822565-2017-03174
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771200964
• Device Lot Number: 62479452
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1