MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes lcp/ liss system; unknown screw/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article yolanda hernanz gonzalez, andres diaz martin, fernando jara sanchez, and carlos resines erasun (2007), early results with the new internal fixator systems lcp and liss : a prospective study, acta orthopaedica belgica vol.73(1), pages 60-69, (spain).The aim of this study was to investigate the results of an initial application of the lcp and liss across a wide range of indications and to make conclusions relevant for routine clinical application.Between october 2002 and april 2005, a total of 112 patients (36 male and 76 female) with a mean age of 53.1 years (ranges, 21 ¿ 85 years) were included in the study.These patients had 121 injuries and were treated with a new lcp/liss system synthes.The mean duration of follow-up was 20 months.The article did not specify which of the devices were being used to capture the following complications: 1 patient had delayed or non-union.(table 2).1 patients had superficial infection.(table 2).1 patients had wound dehiscence.(table 2).9 patients had implant-related pain.(table 2).1 patient had bone grafting and change of implant after non-union.(table 3).2 patients had debridement after infection.(table 3).12 patients had implant removal.(table 3).1 patient had implant breakage.(table 2).1 patient had reoperation after plate breakage.(table 3).A (b)(6) year-old man had a broken plate and delayed union after nine months nad was treated successfully iwht removal of the broken plate and intramedullary nailing with an 11 mm ctn with proximal and distal locking, in combination with autogenous cancellous bone graft.A (b)(6) year-old woman presented loosening of the implant and loss of reduction.She refused a revision operation.A (b)(6) year-old man presented wound dehiscence and superficial infection and the tibial plate was exposed.This is report 8 of 10 for (b)(4).This report is for an unknown synthes lcp/ liss system; unknown screw.

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: patient code 3191 used to capture device failure.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 - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9193300
• MDR Text Key: 173184546
• Report Number: 8030965-2019-69342
• Device Sequence Number: 1
• Product Code: HWC
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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: 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR