MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Event date: unknown.Udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(6).Manufacturing date: august 05, 2015.Expiry date: july 01, 2020.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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)(4) reports an event in (b)(6) as follows: the patient was implanted with the zipfix system on (b)(6) 2106.Post-operatively the patient presented with mediastinitis.It was confirmed this was not an infection; however, the patient did require a revision to remove a zipfix device on (b)(6) 2016 due to the reaction.The patient outcome was reported as sternal instability due to diastasis.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Investigation summary: the given information on the device report has indicated that there was a re-intervention to remove the zipfix.The complained devices were not returned; therefore, we cannot give a conclusive statement regarding the possible failure reason.Unfortunately, we have received only limited information.Neither further details, nor surgery report was forwarded.Both batches were produced according to the specifications.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error.Dhr reopened because the supplier was missing.Device history records review was conducted.The report indicates that the: dhr review for: part: 08.501.001.01s / lot: 9512981; manufacturing location: (b)(4); supplier: (b)(4); manufacturing date: 05.Aug.2015, expiry date: 01.July 2020.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6226271
• MDR Text Key: 63970236
• Report Number: 9612488-2017-10011
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: 9512981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR