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

Model Number 08.501.001.01S

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.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 a reapproximation of the sternum procedure with sternum plates and screws on (b)(6) 2020, three sternal zipfix were broken.It was believed that the size of the patient may have contributed to the issue.The surgeon stated that he should have used more fixation due to the patient size.The procedure was successfully completed.Patent is recovering.There was no surgical delay.Concomitant device reported: unknown sternum plate (part # unknown, lot # unknown, quantity unknown), unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) sternal zipfix with needle sterile.This is report 3 of 3 for (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.After the devices were received it was determined the devices came from a pack of 20 and were not individual devices so they are captured on manufacturer report number 2939274-2020-01321.

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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.After the devices were received it was determined the devices came from a pack of 20 and were not individual devices so they are captured on manufacturer report number 2939274-2020-01321.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
• 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: 9848095
• MDR Text Key: 193399415
• Report Number: 2939274-2020-01323
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587025971
• UDI-Public: (01)10887587025971
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08.501.001.01S
• Device Catalogue Number: 08.501.001.01S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA; UNK - ZIPFIX IMPLANTS
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR