MAUDE Adverse Event Report: UMKIRK SYNTHES GMBH (DE) MATRIXMANDIBLE DEPTH GAUGE; GAUGE, DEPTH

Catalog Number 03.503.036

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint condition was not confirmed for the returned device.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 03.503.036.Lot: l232177.Manufacturing site: (b)(4).Release to warehouse date: 16.Dec.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that matrixmandible depth gauge was missing a component.There was no known patient or hospital involvement.This report is for one (1) matrixmandible depth gauge.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE DEPTH GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): UMKIRK SYNTHES GMBH (DE); im kirchenhurstle 4-6; umkirch 79224 ; GM 79224
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13087372
• MDR Text Key: 285044647
• Report Number: 3003862213-2021-00009
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819894365
• UDI-Public: (01)07611819894365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.036
• Device Lot Number: L232177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2016
• 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