MAUDE Adverse Event Report: WERK HÄGENDORF (CH) STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE, FIXATION

Catalog Number 08.501.001.05S

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that, patient underwent cabg with zipfix bands for sternal closure and post op the sternal bands got loosen and untied.This report is for one (1) sternal zipfix with needle sterile / 5 pack.This is report 1 of 1 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12324049
• MDR Text Key: 266619272
• Report Number: 2939274-2021-04674
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 7611819432505
• UDI-Public: (01)7611819432505
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 07/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.501.001.05S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention