MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/; DRILL, BONE, POWERED

Catalog Number 03.503.476S

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes, reports an event in the (b)(6) as follows: it was reported that, on (b)(6) 2019, during an unknown procedure there was an issue with the trans-buccal drill bits.None would cut and one broke, tips blackened.No fragments were left in the patient.A standard intra-oral drill bit was used as a replacement.This complaint involves four (4) devices.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).H3 h6: investigation summary the complaint condition that the drill bit did not cut or broke during use, cannot be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: a review of the device history record.Device history lot part: 03.503.476s, lot: 5l61794, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 06.Aug.2019, expiry date: 01.July 2029.Device was first manufactured unsterile under the lot u341904 in by a us supplier and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 03.503.476 with lot u341904 were reviewed: 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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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

Update: this report is 5 of 6 for (b)(4).

• Brand Name: BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9474167
• MDR Text Key: 195410942
• Report Number: 8030965-2019-71126
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819351479
• UDI-Public: (01)07611819351479
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476S
• Device Lot Number: 5L61794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1