MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; CERCLAGE FIXATION

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.The 510k: this report is for an unknown zipfix implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone not available for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 being filed after the review of the following journal article: korymasov y.A., pushkin s.Y., benyan a.S.And medvedchikov m.A.(2016).Strategy and tactics for the surgical treatment of infectious complications following a sternotomy.Wounds and wound infections.Journal of the name of prof.B.M.The costume.Volume 2, number 4.Pages 15-26.((b)(6)) this study was done to validate the principles of the surgical treatment of purulent infections of the sternum and anterior mediastinum following the performance of a sternotomy entry.Over the period extending from 2008 through 2015, 95 patients (63 men and 32 women with an average of 60.1 ± 8.7 years old) were treated due to purulent complications following sternotomies previously performed at other treatment and prevention facilities.Surgical tactics were selected as a function of the nature and depth of the tissue injury; superficial sternal wound infections, (sswis) with 46 cases and deep sternal wound infections, (dswis) with 49 cases.Seven patients under dswi were implanted with unknown synthes zipfix sternal retainers with a polyetheretherketone (peek) needle.Complication were reported as follows: complications associated with the unknown synthes zipfix sternal retainers with a polyetheretherketone (peek) needle; re-separation of the sternum¿s edges was noted in one patient 1 month after surgery.Among the 49 patients with acute anterior sternomediastinitis, 8 died.Dswi¿s were presented in all the patients that died.Progression of the infectious process, sepsis was observed in 2 patients.These complications were not clearly identified in the article to be associated with the reported synthes device.This report is for an unknown synthes zipfix retainers and unknown synthes polyetheretherketone (peek) needle.This report is 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7550633
• MDR Text Key: 109514033
• Report Number: 8030965-2018-54016
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention