MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUBBER DAM PUNCH; M51 - GENERAL DENTISTRY

Catalog Number 766A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported that the tip of the 766a rubber dam punch broke off in a patient's mouth during an unspecified dental procedure on (b)(6) 2020.They were able to retrieve it without causing harm to the patient.There was no known delay in surgery.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h6, h10.Udi#: (b)(4).The rubber dam punch was not returned (discarded by customer) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).766a rubber dam punch was received for evaluation.The returned rubber dam punch was in used condition with the tip broken off due to physical damage.The reported complaint is confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: RUBBER DAM PUNCH
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10715798
• MDR Text Key: 214589756
• Report Number: 2523190-2020-00118
• Device Sequence Number: 1
• Product Code: EJG
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2020

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: Health Professional
• Device Catalogue Number: 766A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/19/2020; 01/11/2021
• Supplement Dates FDA Received: 12/09/2020; 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1