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

Catalog Number 388.038

Device Problem Component Missing (2306)

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

Event Date 08/02/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a posterior cervical fusion using synapse procedure, the surgeon wanted to put a transverse connector between the rods, however the crimper which is used to lock the ends of the transverse connector was broken.A necessary screw was missing from crimper, preventing the crimper to be functional.The surgeon put the end of a thin instrument into the screw hole to provide the fulcrum that the screw would usually provide.This worked, however, the surgeon felt that it did not crimp as strongly as usual.The missing screw was found on the theatre floor at the end of the case.It was reinserted; however a piece of welding that usually keeps it in place has broken off.There was a ten minutes delay in the procedure.There was no impact to patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 material which was delivered as lot 44420 is corresponding to the specifications.No non-conformance reports were generated during production.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: CRIMPER FOR TRANSCONNECTOR
• Type of Device: INSTRUMENT COMPRESSION
• 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: 4043819
• MDR Text Key: 4728728
• Report Number: 9680938-2014-10056
• Device Sequence Number: 1
• Product Code: HWN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• 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: T954645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• 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
• Patient Age: 73 YR