MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Model Number 03.501.080

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part no.: 03.501.080, lot no.: 7797648: manufacturing location: (b)(4), release to warehouse date: 12.Mar.2012: 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.A product investigation was performed.The application instrument for sternal zipfix (part: 03.501.080, lot: 7797648, mfg: 12-mar-2012 was received with the reported condition of ¿will not cut/dull nrm.¿ the device was initially received at service and repair.The customer reported the instrument was not cutting the zip fix.The repair technician reported that part of the cutting tip was broken off and missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.At customer quality, the returned application instrument for sternal zipfix was inspected and the complaint was confirmed.Visual inspection performed at customer quality observed that the proximal portion of cutter was broken and the fragments were not returned.No new malfunctions have been identified.Whether this complaint could be replicated is not applicable because the device was returned damaged.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for application instrument for sternal zipfix 03.501.080, and sternum tie and determined to be suitable for the intended design and application when used as recommended.Dimensional analysis was not able to be performed due to missing broken fragments and post manufacture breakage.A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that any excessive unintended forces encountered by the device during usage or handling could have contributed to the broken complaint condition of this 6+ year old reusable instrument.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

Event Description

It was reported that an application instrument for sternal zipfix is not cutting the zipfix.The issue was identified during cleaning.This complaint does not involve a patient or procedure.During manufacturer¿s investigation of the returned device it was identified that the part of the cutting tip was broken off and missing.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.This is report 1 of 1 for complaint (b)(4).

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• 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 HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7484024
• MDR Text Key: 107364374
• Report Number: 2939274-2018-51996
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 7797648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1