MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM; PLATE,FIXATION,BONE

Catalog Number 04.130.212S

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent open reduction internal fixation surgery for the proximal phalanx fracture of the right third toe with the variable angle locking screw.During the distal screw insertion the screw broke when the surgeon tried to remove it because he inserted the screw in a different direction from a pilot hole direction.The fragment of the screw (about 8mm) was buried in the bone.The tip of the fragment (about 1mm) was out of the bone.The surgeon tried to remove the fragment with a needle-nose plier, but was unable to.The surgeon gave up removing the fragment and inserted all other screws.The surgery was delayed by ten (10) minutes, and extra bleeding occurred.The surgeon commented that the breakage of the screw might be caused by the excessive load because he inserted the screw into the different direction from a pilot hole at steep angle.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).Unknown plate (part# unknown, lot# unknown, quantity# 1).Unknown screws (part# unknown, lot# unknown, quantity# unknown).This report is for one 1.5mm ti va-lckng scr slf-tpng with t4 stardrive recess 12mm.This is report 1 of 1 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 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: 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9785231
• MDR Text Key: 193011136
• Report Number: 8030965-2020-01620
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07612334092274
• UDI-Public: (01)07612334092274
• Combination Product (y/n): N
• PMA/PMN Number: K141527
• 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: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.130.212S
• Device Lot Number: 5L08309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA; VA LOCKSCR Ø1.5 SELF-TAP L12 TAN
• Patient Outcome(s): Required Intervention