MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The root cause of this event cannot be conclusively determined with the available information, however it is possible the event was due to improper technique (use of the instrument without the corresponding counter torque wrench) and misuse (using the blocker holder to perform final tightening).If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report one of four for the same event, reference 3003853072-2016-00017 through 3003853072-2016-00019.

Event Description

It is reported the surgeon experienced difficulty inserting the nut.He felt the diameter of nut was small and the shape and blade of screwdriver is narrow.The surgeon decided to verify with x-ray, because there was a probability while placing the screw that it can get beyond the vertebrae.X-rays were used during the surgery in order to control the placement of the transpedicular fixation system.It is reported the surgeon made four times more x-rays during this surgery than another surgery due to the issue reported.A surgical delay of 30 minutes was reported.The surgeon decided to use another system.It is reported the instinct final screwdriver was damaged during final tightening step.The instinct torque limiting t-handle was used for blocker final tightening, however the counter torque wrench was not used.In addition, it was reported the surgeon knew the blocker holder instrument should be used to hold the blocker, however he used it for final tightening.

Manufacturer Narrative

A follow up report will be sent upon completion of the device evaluation.Supplemental report one of four for the same event, reference 3003853072-2016-00017-1 through 3003853072-2016-00019-1.

Manufacturer Narrative

The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The visual evaluation of the two returned devices showed that the instinct final screwdriver ref (b)(4) has the thread part twisted and not broken.The method of the twisting (tightening or untightening) cannot be determined, however the customer reported that the instinct final screwdriver ref (b)(4) was damaged during tightening step.To conclude, based on the information available and on the investigation, the most probable root cause of this issue can not be determined.Date received by mfr, if follow up, what type?, device evaluated by mfr?, device manufacture date, and evaluation codes were updated based on the completion of the device evaluation.(b)(4).Supplemental report one of four for the same event, reference 3003853072-2016-00017-2 through 3003853072-2016-00019-2.

• Brand Name: FINAL SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047419468
• MDR Report Key: 5507406
• MDR Text Key: 40565979
• Report Number: 3003853072-2016-00016
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W1AN00640
• Device Lot Number: A2006731A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other