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

Model Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 procedure on (b)(6) 2018 the cutting arm of the zipfix application instrument was not locking back into the instrument causing the ratcheting mechanism not to work without the surgeon holding the cutting arm in place.Upon further examination, it appeared that the portion of the instrument that holds the cutting arm in place is bent.The surgeon was able to finish the procedure without incident and there was no report of surgical delay.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 03.501.080, lot# 9724102.Manufacturing location: (b)(4), release to warehouse date: may 17, 2016.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service and repair evaluation was completed.The customer reported the cutting arm was not locking back into the instrument which caused the ratcheting mechanism not to work.The repair technician reported the right spring stop was bent which was making the trigger stick.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The item was forwarded to customer quality (cq).Product development investigation was completed.The device was received at cq intact but with a bent right spring stop as reported by service and repair.The spring stop is bent slightly outwards and upwards in the direction the lever arm would move to cut the implant.This condition causes the lever arm to sit proud between the two stop springs causing the internal mechanism to run against the stop adding resistance to the tensioning mechanism.It was noted that if additional force was applied, pushing the lever arm further into the lock position, the trigger then could move though the full range of motion with no additional resistance.No further issues were observed.Thus, the complaint condition is confirmed and consistent with the reported condition.The resulting functional issue can be replicated but replication of the bent condition is not applicable as the device is already deformed.No service history review can be performed as part number 03.501.080 with lot number(s) 9724102 is a lot/batch controlled item.Based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The thickness of the stop spring where the component thins and bends outward was inspected.It was found to measure 0.75/0.77mm which is within the specification of 0.8mm +/-0.05 per the drawing.(calipers ca102p).The difficulty tensioning is determined to be a result of the bent strop spring.The cause of the bent stop spring could not be definitively determined due to the unknown factors during use and over the lifetime of the instrument.However, the condition is consistent with exposure to an upward force, applied to the lever or the spring directly, which would lead to bending of the locking spring.There is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during the course of this investigation.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: 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7225461
• MDR Text Key: 98534059
• Report Number: 2939274-2018-50423
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)9724102
• 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,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 9724102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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