MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: SPINE

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown drill bits: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 a procedure involving right lateral mass, c7, the drill bit snapped at 14mm and was lodged in the patient.The surgeon was attempting to fit a planned 3.5x14mm synapse cancellous screw when the break occurred.The surgeon removed the broken drill bit from the patient.There was a surgical delay of five to ten (5-10) minutes.The patient status was reported as okay at the conclusion of the case.Concomitant devices reported: unknown synapse cancellous screw (part # unknown, lot # unknown, quantity # 1), unknown drill guide (part # unknown, lot # unknown, quantity # 1).This report is for one (1) unk - drill bits: spine.This is report 1 of 1 for (b)(4).

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.H11: d10: product was not returned, complainant part is not expected to be returned for manufacturer review/investigation.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: UNK - DRILL BITS: SPINE
• Type of Device: DRILL BIT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10637059
• MDR Text Key: 210084887
• Report Number: 8030965-2020-07755
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• 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: 09/16/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: SPINE; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - LOCKING/SET SCREWS: SYNAPSE; UNK - LOCKING/SET SCREWS: SYNAPSE; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - LOCKING/SET SCREWS: SYNAPSE