MAUDE Adverse Event Report: ZIMMER DENTAL TSV INSTRUMENT KIT COMPLE; SURGICAL KIT

Catalog Number TSVKIT

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's identifier unknown/ not provided.Patient's age unknown/ not provided.Patient's weight unknown/ not provided.

Event Description

It was reported that when the customer he opened the kit (tsvkit) drills had corrosion on them.He was unable to complete the surgery.The patient was in the chair with the surgical flap opened.He noticed the corrosion on the tap drill and had to close the site back up and send the patient home.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One tsv instrument kit comple (tsvkit) was returned for investigation.Visual inspection of the as returned product identified minor signs of use and oxidation/rust on some of the components.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Appropriate documentation was reviewed and the following information was identified: documents reviewed: instructions for use for zimmer® instrument kit system and driva¿ drills 8874 rev 4-07/14 information identified: precautions product packaging cleaning/sterilization information.It was reported that when the customer opened the kit (tsvkit) drills had corrosion on them.He was unable to complete the surgery.The patient was in the chair with the surgical flap opened.He noticed the corrosion on the tap drill and had to close the site back up and send the patient home.The reported complaint was confirmed during visual inspection.A definitive root cause for this complaint could not be determined.The following sections have been updated: date of this report.Expiration date, udi: (b)(4).Date received by manufacturer.Type of report, follow-up number.Follow up type.Device evaluated by manufacturer: change ¿no' to 'yes'.Device manufacture date.Evaluation codes.Additional narrative.The following sections have been corrected: h5: labeled for single use.

• Brand Name: TSV INSTRUMENT KIT COMPLE
• Type of Device: SURGICAL KIT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8445992
• MDR Text Key: 139670046
• Report Number: 0002023141-2019-00126
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TSVKIT
• Device Lot Number: 63832797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention