MAUDE Adverse Event Report: SYNTHES TUTTLINGEN CABLE CUTTER-STANDARD; CUTTER, WIRE

Catalog Number 391.905

Device Problem Component Missing (2306)

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

Event Date 06/10/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that the handle of the zipfix application instrument stayed in the closed position during a sternal closure procedure on (b)(6) 2015.Also, it was discovered that one of the zipfix cable cutters was missing a tip blade when it came out of the set.Replacement devices were available for use.The procedure was completed successfully with no reported surgical delay.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the device history records has been requested and is pending completion.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.

Manufacturer Narrative

Additional narrative: device history review: manufacturing date: may 16, 2013.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw materials, which were delivered as lot 7344306 (for carbide inserts), kr91879 (for body), and kr87611 (for the jaws) are corresponding to the specifications.The hardness was measured at the time of manufacturing between 48.2-48.8 hrc for 1.4021 and was found to be good.No non-conformance reports were generated during production.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.

Manufacturer Narrative

Additional narrative: a device evaluation investigation was performed: one cable cutter, standard (part number 391.905, lot number t990483) was received with the complaint that one of the tip blades was missing when it came out of the set.The complaint condition is confirmed for cable cutter as it is missing one of the carbide cutting tips.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Further evaluation at the chu shows that this device is used in the orthopedic cable system and the sternal zipfix system and used for cutting cables and the zipfix implants.Information is provided in technique guides.The returned device was received with the carbide insert on the left jaw sheared off.The insert was not received.There are flattening marks on the distal end of the device.The balance is in good condition.Thus, the complaint condition for this device is confirmed but cannot be replicated as the carbide insert is already missing.A review of the current design drawing was performed.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.

• Brand Name: CABLE CUTTER-STANDARD
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4868781
• MDR Text Key: 6060500
• Report Number: 9680938-2015-10055
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2015

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 Catalogue Number: 391.905
• Device Lot Number: T990483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2015; 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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