MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4) device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Service history review: part no.03.501.080, lot no.Unknown: no service history review can be performed because the lot number cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the zipfix gun isn't tensioning.This was discovered during a procedure; there was a ten to fifteen (10-15) minute delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Service history review: part no.03.501.080, lot no: 8656993: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 16october2013.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the zipfix gun would not tension.The repair technician reported the lever was sticky.Lube/oil/clean is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item was forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: the complaint condition is confirmed as the repair technician reported the lever was sticky prior to return to the complaint handling unit (chu).Review of the failure mode determined that it is most probable that not properly maintaining the devices as indicated in the technique guide resulted to the complaint condition.Furthermore, upon receipt at the chu, it was noted that the handling and cleaning of the device appeared to have restored functionality.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.Per the technique guide, the device is part of the sternal zipfix system and used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in technique guide.The device was received intact with only a few minor wear marks on the surface of the device.When the cutting mechanism is locked, the trigger compresses and releases as intended and all components move fully through their range of motion.When the cutting mechanism is unlocked, the lever arm functions as intended and the trigger is locked as intended so that the device would not cut with the implant under tension.Thus, no functional issue was identified.However, as the repair technician reported the lever was sticky prior to return to the chu, the complaint condition is confirmed, consistent with the reported condition, and could be replicated.Review of the failure mode determined that it is most probable that not properly maintaining the devices as indicated in the technique guide resulted to the complaint condition.This is further evident in that the handling and cleaning of the device prior to receipt at the chu appears to have restored functionality.Specifically, it appears binding can occur between the spacer component and the pusher sleeve component when not adequately lubricated as this is where the tolerance is tightly constrained to allow a sliding fit and to ensure proper alignment between the components.A review of the design drawing for the top level assembly was performed.The following component drawings were also reviewed; spring assembly, lever, small arm, pusher assembly, spacer, and pusher sleeve.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.

Manufacturer Narrative

Device 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): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5229247
• MDR Text Key: 31338682
• Report Number: 2520274-2015-17323
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• 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,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8656993
• Other Device ID Number: (01)10887587010847(10)8656993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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