MAUDE Adverse Event Report: K2M, INC. DENALI MI SPINAL SYSTEM; WRENCH

Catalog Number	1001-90133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.If more information becomes available manufacturer will file a follow-up report at that time.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that the tip of a torque wrench broke off in a set screw intra-op and remains in the patient.Surgery took place (b)(6) 2016.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.The tip of a torque indicating wrench sheared off intra-operatively and was left in the set screw inside the patient.Testing indicates that the tip will fail under approximately 150 ± 9 in-lbs.Since the torque wrench is rated for 98 ± 8 in-lbs, the tip likely sheared off due to over-torquing the set screw, which is consistent with misuse of the instrument, or due to the handle being out of spec.However, since the instrument was not returned, no definitive conclusions could be made.A general review of the manufacturing and inspection records contributed no additional information.Not returned.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2016 that the tip of a torque wrench broke off in a set screw inside the patient.Surgery took place (b)(6) 2016.

• Brand Name: DENALI MI SPINAL SYSTEM
• Common Device Name: WRENCH
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 5778843
• Report Number: 3004774118-2016-00048
• Device Sequence Number: 1457322
• Product Code: HXC
• UDI-Device Identifier: 10888857001121
• UDI-Public: 10888857001121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 1001-90133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1