MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DEPTH GAUGES; GAUGE,DEPTH

Catalog Number UNK - DEPTH GAUGES: TRAUMA

Device Problem Mechanical Jam (2983)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown depth gauges: trauma/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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: this pc is related to (b)(4) which reports about the radiolucent drive.This pc reports about the drill bit.It was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery with the nail and the drill bit in question.During the drill with the drill bit and the radiolucent drive, the surgeon could not drill at all.The surgeon hammered the drill bit to make a pilot hole and drilled to the opposite cortex.The surgeon could not remove the drill normally, and he removed the drill with a pliers.The surgeon tried to insert a depth gauge a few times, but he couldn¿t.The surgeon confirmed by image intensifier that the fracture occurred at the distal nail.The surgeon made an incision, and he used 3 wires to fix the fracture.The surgeon commented that it was possible that the fracture occurred when the surgeon hammered the drill.The surgery was completed successfully with 60 minutes delay.No further information is available.Concomitant device reported: unknown locking screws (part # unknown, lot # unknown, quantity unknown), unknown end cap (part # unknown, lot # unknown, quantity 1), unknown depth gauge (part # unknown, lot # unknown, quantity 1), unknown radiolucent drive (part # unknown, lot # unknown, quantity unknown).This complaint involves four (4) devices.This report is for one (1) unk - depth gauges.This report is 4 of 4 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.B5: updated information provided for reporting.H3, h6: investigation summary: 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.D11: updated concomitant product provided for reporting.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

06/04/2020: updated ed: concomitant device reported: unknown locking screws (part # unknown, lot # unknown, quantity unknown), unknown end cap (part # unknown, lot # unknown, quantity 1), unknown radiolucent drive (part # unknown, lot # unknown, quantity unknown).This complaint involves four (4) devices.

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 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

This report is 4 of 5 for (b)(4).

• Brand Name: UNK - DEPTH GAUGES
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10080149
• MDR Text Key: 194132965
• Report Number: 8030965-2020-03674
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - DEPTH GAUGES: TRAUMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0; DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0; HN MULTILOC Ø8.5 IZQ CAN L195 TAN; HN MULTILOC Ø8.5 IZQ CAN L195 TAN; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; UNK - DEPTH GAUGES; UNK - DEPTH GAUGES; UNK - END CAPS: HUMERAL NAIL; UNK - END CAPS: HUMERAL NAIL; UNK - RADIOLUCENT DRIVE; UNK - RADIOLUCENT DRIVE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention