MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION

Model Number 08.501.001.05S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

It was reported that during closing of the sternotomy after performing an aortic root procedure on (b)(6) 2018, the tie of the sternal zipfix broke prematurely while being applied with tension.There were four other zip ties that were successfully tightened and cut after the first tie broke.The surgeon felt the sternum was stable and left the fifth point of fixation off.There was no surgical delay reported.Broken device was easily removed.No reported patient consequences.Procedure was successfully completed.Concomitant device reported: application instrument (part# unknown, lot# unknown, quantity 1).This report is for one (1) sternal zipfix with needle sterile / 5 pack.This is report 1 of 1 for (b)(4).

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 no.: 08.501.001.05s; lot no.: l697046; manufacturing location: bettlach; supplier: (b)(4); release to warehouse date: january 17, 2018; expiry date: january 31, 2023.No nonconformance records (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.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Investigation summary: the following investigation flow was performed: broken.Visual inspection performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.The returned zipfix implant has a transverse break and only the proximal portion of the broken tie was returned for analysis.The material surface at the fracture site appears homogeneous with no voids when viewed under 5x magnification.The returned device was manufactured in january 2018.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.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The width of the returned device near breakage measured 4.23mm at cq (ca592) which is within specification of 4.22mm +/-0.1mm per the device drawing.The thickness of the returned device near breakage measured 1.90mm at cq (ca592) which is within specification of 1.9mm +0.1/-0.15mm per the device drawing.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.A defintive root cause was unable to be determined based on the provided information.It is possible that excessive tension was applied to the device resulting in breakage.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.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7574185
• MDR Text Key: 110581977
• Report Number: 2939274-2018-52423
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 20887587025985
• UDI-Public: (01)20887587025985
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 08.501.001.05S
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: L697046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR