MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT

Model Number N/A

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It is reported when the surgeon locked the blockers, the final screwdriver shaft broke.The part of the instrument that broke remained inside the blocker and was unable to be removed from the blocker, which remains implanted in the patient.A second driver was used to successfully complete the surgery.

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 returned device confirmed that the driver is broken above the thread part.The chemical analyzes of the screwdriver showed that the raw material and hardness were conforming to specification.The micrographic analysis showed no surface defects and no metallurgical defects.The surgical technique states "always use the torque limiting t-handle for final tightening." the return of the torque limiting t-handle used during the surgery was requested and received.The functional evaluation of the instinct torque limiting t-handle showed that the torque handle used during this surgery is non conforming.The review of the device history record of the instinct torque limiting t-handle (046w1an00650 lot a164720901) showed that no non conformity was registered.The unit was received and released in may 2012.The lifetime, determined in the device history files, for the instinct torque limiting t-handle is 3 years.In this case, the instinct torque limiting t-handle was used 3 years and 6 months ((b)(6) 2012 to (b)(6) 2015), therefore the root cause is product exceeded useful life, normal wear.The root cause for the instinct final screwdriver breakage is the off axis use of the screwdriver with the instinct torque limiting t-handle.Corrections to initial report: device product code is nkb, not hxx.Pma/510(k) number is k111301, not exempt.As the instinct torque limiting t-handle was identified to have caused or contributed to the reported event, an mdr was submitted for this device (reference 3003853072-2016-00015).

• Brand Name: FINAL SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cité mondiale; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cité mondiale; bordeaux 33080 ; FR 33080
• Manufacturer Contact: michelle cole ; 23 parvis des chartrons; cité mondiale; bordeaux 33080 ; FR 33080 ; 0033556001
• MDR Report Key: 5305548
• MDR Text Key: 33719693
• Report Number: 3003853072-2015-00023
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• 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: 046W1AN00641
• Device Lot Number: A2102902A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other