MAUDE Adverse Event Report: SYNTHES TUTTLINGEN CRIMPER FOR TRANSCONNECTOR; INSTRUMENT COMPRESSION

Catalog Number 388.038

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

No reported patient or direct surgical involvement.Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing date: week 41, year 2005.The device history record is no longer available due to the age of the instrument (over 10 years old).Therefore, the exact date of manufacture is unknown.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.

Event Description

It was reported that the tip of a crimper for transconnector broke during sterile processing on (b)(6) 2016.The tiny fragmented tip of the device could not been found.As the breakage occurred prior to a surgery, no direct patient or procedural involvement has been associated with the event.The product's malfunction did not delay the start of the procedure.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device is currently undergoing investigation; the results are pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product investigation summary: the returned instrument was examined and the complaint condition was confirmed as both of the bottom distal prongs were bent and one prong was broken off.No definitive root cause was able to be determined; however, the failure mode is likely contributable to the application of excessive force/rough handling over 10 years in the field.A visual inspection under 5x magnification, a device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The crimper for transconnector is utilized in both the synapse and axon systems to lock transconnectors after implantation.The relevant drawings for the returned instrument were reviewed: top-level.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.No new, unique, or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: CRIMPER FOR TRANSCONNECTOR
• Type of Device: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5754847
• MDR Text Key: 48315611
• Report Number: 9680938-2016-10090
• Device Sequence Number: 1
• Product Code: HWN
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.038
• Device Lot Number: A7OA41
• Other Device ID Number: (01)10705034771755(10)A7OA41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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