MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Device returned.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 europe reports an event in india as follows: it was reported that a failure of trigger of zipfix applicator during bilateral mammary cabg surgery.Hospital name; (b)(6).Surgeon name; dr.(b)(6).Was surgery delayed due to the reported event? no.Action taken when event occurred? steel was used in place of sternal band zipfix.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: unknown, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? unknown at this stage, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Event Description

The procedure occurred on (b)(6) 2019.

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.Part: 03.501.080; lot: 9893634; manufacturing site: hägendorf; release to warehouse date: june 09, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: 2nd generation instrument design with no visual evidence of extensive use on the trigger component.(scratch marks).Functional test: the functional tests performed on the returned device, after its lubrication according to the surgical technique, shows that the device is fully functional as per its design intend.Document/specification review: the article has passed the function test, no issue could be confirmed, and therefore no document/specification review is needed.Dimensional inspection: the article has passed the function test, no issue could be confirmed, and therefore no dimensional inspection is needed.Summary: the functional tests performed on the returned device, after its lubrication according to the surgical technique, shows that the device is fully functional as per its design intend.Therefore, the ¿not lubricated¿ condition of the returned device is identified as the root cause regarding the intra operative instrument mail function.No design related issue was identified on the returned device.This complaint is therefore closed by the product development as invalid.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Manufacturer contact information.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: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8857334
• MDR Text Key: 153231275
• Report Number: 8030965-2019-66842
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9893634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention