MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK; CERCLAGE FIXATION

Model Number 08.501.001.20S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part no.: 08.501.001.20s, lot no.: l656550: manufacturing location: (b)(4), supplier: (b)(4), release to warehouse date: 06.Dec.2017, expiry date: 01.Nov.2022.No non-conformance reports (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.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 an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2018, the surgeon put the patient safety & learning system (psls) for zipfix in patient and secured it but it came undone.The surgeon was unable to re-insert it.A new zipfix strap was opened and the case was completed.No additional information is available.This report is for sternal zipfix with needle sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7500239
• MDR Text Key: 107957573
• Report Number: 2939274-2018-52120
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 20887587025992
• UDI-Public: (01)20887587025992
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: 08.501.001.20S
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L656550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1