MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER; PLATE, FIXATION, BONE

Catalog Number 04.117.004S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot: expiry date: 01.Jan.2030.Device history batch: part: 04.117.004s, lot: 32p8239, manufacturing site: (b)(4), release to warehouse data: (b)(4).Dez.2019 a manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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 a surgery for distal humeral fracture using va-dhp and the locking screw.During the surgery, the surgeon could not lock the locking screw (16 mm in length) with the plate.He tried another locking screw (14 mm in length), but it could not be locked.The surgeon gave up inserting the screw into the screw hole of the plate because he suspected the thread part of the hole was broken.The surgery was delayed by less than thirty (30) minutes.No further information is available.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 2.7/3.5 ti va-lcp postlat dhp- lat supt 4h/rt/88mm-med-ster this is report 2 of 3 for (b)(4).

Event Description

Concomitant devices reported: screwdriver (part# unknown, lot# unknown, quantity# 1); va lockscr ø2.7 head 2.4 self-tap l14 ta (part # 04.211.014s, lot # 6l54056, quantity 1), va lockscr ø2.7 head 2.4 self-tap l16 ta (part # 04.211.016s, lot # 6l41867, quantity 1).

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.H6: 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.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: 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9982186
• MDR Text Key: 191425026
• Report Number: 8030965-2020-02973
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819586369
• UDI-Public: (01)07611819586369
• Combination Product (y/n): N
• PMA/PMN Number: K120717
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.004S
• Device Lot Number: 32P8239
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWDRIVERS; UNK - SCREWDRIVERS; UNK - SCREWS: LOCKING; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA