MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM-STERILE

Catalog Number 03.019.016S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a synthes 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 surgery to insert a long multiloc nail, the 3.8-diameter drill bit broke.There were no fragments generated.There was no surgical delay.The surgery was completed successfully.There was no consequence to the patient.Concomitant device reported: drill: (part number unknown, lot unknown, quantity unknown).Nail: (part number unknown, lot unknown, quantity, unknown).This report involves one (1) 3.8mm three-fluted drill bit qc/calibrated/270mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM-STERILE
• Type of Device: BIT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10223473
• MDR Text Key: 197297476
• Report Number: 8030965-2020-04616
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819433762
• UDI-Public: (01)07611819433762
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNK - NAILS.
• Patient Age: 53 YR
• Patient Weight: 80