MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PITUITARY RONGEUR BLACK 3MM LATERAL

Catalog Number 8733-7153

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

A broken rongeur was returned to the manufacturer.No information is available regarding when the breakage occurred or any possible patient impacts.

Manufacturer Narrative

D10 was entered in error, there is no change or addition to the previously reported information for this field.The returned rongeur was confirmed for the reported failure of fractured tip.Since the device was discovered during processing, the fracture event and its circumstances are unknown, and the cause cannot be conclusively determined.There were no other signs of damage on the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

A broken rongeur was returned to the manufacturer.No information is available regarding when the breakage occurred or any possible patient impacts.

• Brand Name: PITUITARY RONGEUR BLACK 3MM LATERAL
• Type of Device: RONGEUR
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8869851
• MDR Text Key: 153575904
• Report Number: 3012447612-2019-00332
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8733-7153
• Device Lot Number: IM00281
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1