MAUDE Adverse Event Report: ZIMMER INC, UNKNOWN NEXGEN RETRACTOR; KNEE INSTRUMENT

Catalog Number UNKNOWN NEXGEN INSTRU

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The product and lot number was not provided.Also, no product has been returned for review.The device was used for treatment.There is insufficient information to investigate any further or review any of our design documents.If any new information is received regarding the product the complaint will be re-opened for evaluation.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

Nexgen patella reamer is catching during reaming and jerking the drill to the side.

• Brand Name: UNKNOWN NEXGEN RETRACTOR
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER INC,; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw 46581-0708 ; 8006136131
• MDR Report Key: 5565409
• MDR Text Key: 42454589
• Report Number: 1822565-2016-01018
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN NEXGEN INSTRU
• Device Lot Number: UNKNOWN REAMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1