MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE WRENCH

Catalog Number 277040510

Device Problem Output above Specifications (1432)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon was using both instruments.Both torque screwdriver tips are stripped.Torque handle required excessive pressure to successfully tighten the set screw.Tlif distractor fell apart once inserted.Metal circle, where it's welded, fell off.Metal piece that broke off from tlif distractor was retrieved.Surgeon removed piece from spine.

Manufacturer Narrative

(b)(4).The torque wrench handle (product code: (b)(4), lot number: e0508) was returned to the complaints handling unit (chu).The torque wrench showed heavy signs of use.Its surface anodization was heavily faded and covered with nicks and surface abrasion.The wrench remained stuck at its (b)(6) in*lb setting and could not be shifted.Torque testing was performed on this instrument.The amount of torque exerted by the handle remained within spec at its (b)(6) in*lb setting.Although subtle and not immediately visible, a lack of maintenance may have begun to influence the components of the handle, resulting in the handle torque setting becoming stuck at (b)(6) in*lb.However, the handle is within spec at this setting.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the torque wrench handle¿s torque setting becoming stuck cannot be determined from the sample and the information provided.A potential root cause may be lack of maintenance during its time in use, resulting in wear and rust causing the device to seize.It should be indicated that work instruction (wi-5220 revision l) was incorporated on (b)(6) 2013 which provides definition of the refurbishment process and minor component replacement process which depuy spine instruments shall follow.Specifically, torque wrenches which have a current 12-month date etched on the handle to indicate the date of the required maintenance.Since this torque wrench has been in the field for greater than 7 years, it does not fall within the threshold of depuy¿s refurbishment process per wi-5220 revision l.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE WRENCH
• Type of Device: WRENCH
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5326820
• MDR Text Key: 34334186
• Report Number: 1526439-2015-11109
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 277040510
• Device Lot Number: E0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1