MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARB.B.SURGERY ZEKRYA FG 28MM; BUR, DENTAL

Catalog Number 151-FG28

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

In this event it is reported that carb.B.Surgery zekrya fg 28mm bur broke during use.The broken part penetrated into the alveolar cavity on the lingual side and was lost inside mucosa.Under general anesthesia the broken pieces could be retrieved.Reportedly no bleeding and patient recovered without any problems.

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Investigation: no product and no lot# available.No investigation or dhr review can be done.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: CARB.B.SURGERY ZEKRYA FG 28MM
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18586206
• MDR Text Key: 333836781
• Report Number: 8031010-2024-00005
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 151-FG28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/15/2024
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1