MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - REAMERS

Device Problems Dull, Blunt (2407); Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reamer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).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, the patient underwent the surgery for femoral trochanteric fractures by using the tfna implants.During the surgery, the surgeon, the surgeon tried to pass the flexible shaft-connected reamer head through 2.5mm reamer rod with extension of 900mm, but he was unsuccessful.While checking the reamer, he inserted the flexible shaft-connected reamer head without the 2.5mm reamer rod with extension of 900mm.As a result, the reamer head came off the flexible shaft, because the connection between the flexible shaft and the reamer head was disconnected in the intrathecal space.He attempted to reconnect the flexible shaft, or remove the reamer head with a guide rod by hooking it, or push up the upper condyle with a k-wire, but he failed.The surgeon inserted the nail while the reamer head was left in the patient¿s body.The surgeon was completed with a less-than-30-minute delay.No further information is available.Concomitant device reported: unknown flexible shaft (part# unknown, lot# unknown, quantity# 1); unknown reaming rod (part# unknown, lot# unknown, quantity# 1); unknown k-wire (part# unknown, lot# unknown, quantity# 1).This report is for one (1) unk - reamers.This is report 3 of 3 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.B5/d11: one concomitant device has been reported, please disregard the othrs: unknown k-wire (part# unknown, lot# unknown, quantity# 1).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 - REAMERS
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10360265
• MDR Text Key: 209156336
• Report Number: 8030965-2020-05585
• Device Sequence Number: 1
• Product Code: HTO
• 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: 07/13/2020

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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNREAM REAMER HEAD Ø13; UNK - FLEXIBLE SHAFTS; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - REAMING RODS
• Patient Outcome(s): Required Intervention