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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION
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OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION Back to Search Results
Catalog Number 08.501.001.01S
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is unknown due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter phone and email are not available for reporting.Initial reporter is a synthes employee.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
Device report from synthes (b)(6) reports an event as follows: it was reported that three (3) sternal zipfix w/needle polyetheretherketone (peek) single packs did not fix during a coronary artery bypass surgery on (b)(6) 2018.Another zipfix was used to complete the procedure.There was no adverse event on the patient.It was unknown if there was a surgical delay.This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
Additional narrative: date information became available to report was reported wrongly as 08/30/2018 and should be 10/30/2018 within (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.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: the device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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.
 
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 history record (dhr) review: part: 08.501.001.01s; lot: l226901; manufacturing site: bettlach; supplier: samaplast ag; release to warehouse date: 02 july 2017; expiry date: 01 january 2022.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product development (pd) investigation was performed because the three implants were incomplete upon receipt for examination and cut into various parts.A functional check could not be performed on these incomplete zipfix portions.Pd investigation site: sustaining engineering zuchwil.For detailed investigation see attached investigation report from sustaining engineering zuchwil under notes & attachments.Summary of the pd investigation: sustaining engineering did not identify any design related root cause which explains the mal function of the devices returned.The removal of the needle at the reduced cross-sectional area right behind the needle is not according the surgical technique guide 036.001.285 ae dsem/cmf/0914/0039) page 10 (step 2, remove sternal zipfix needle).The implant manufacturer states that the device needle must be removed by cutting the implant peek body.Therefore, this non-manufacturing investigation is closed by sustaining engineering as in-valid.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
 
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Brand Name
STERNAL ZIPFIX WITH NEEDLE STERILE
Type of Device
CERCLAGE FIXATION
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7894578
MDR Text Key120968335
Report Number8030965-2018-56504
Device Sequence Number1
Product Code JDQ
UDI-Device Identifier07611819418400
UDI-Public(01)07611819418400
Combination Product (y/n)N
PMA/PMN Number
K110789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Catalogue Number08.501.001.01S
Device Lot NumberL226901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Date Manufacturer Received11/07/2018
Patient Sequence Number1
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