MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX 1.1MM DRILL BIT MQC/8MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 03.503.288

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Additional procode: erl, hbe.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j employee.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 (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure, two drill bits broke.A 1.1.Mm drill bit with 8mm stop broke and a broken part remained in the patient.A 1.1mm drill bit with 12mm stop broke and the broken parts were easily removed.There was no surgical delay reported.There was patient consequence.The procedure was successfully completed using another drill bit.This report is for one (1) matrix 1.1mm drill bit mqc/8mm stop/44.5mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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 history lot part # 03.503.288, synthes lot # u318446, supplier lot # u318446, release to warehouse date: aug 9, 2018; march 11, 2019; nov 5, 2019; april 11, 2019 , supplier: (b)(4), no ncr's were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: MATRIX 1.1MM DRILL BIT MQC/8MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10357309
• MDR Text Key: 202157688
• Report Number: 8030965-2020-05559
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819994775
• UDI-Public: (01)07611819994775
• 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
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.288
• Device Lot Number: U318446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Patient Outcome(s): Required Intervention