MAUDE Adverse Event Report: K2M, INC. SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7601-90003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Manufacturing date for lot ghec is 31/jan/2018, lot gmhc is 07/mar/2018.2 of the 4 devices have been returned and are pending evaluation.A supplemental vmsr will be submitted upon completion of investigation.
Event or Problem Description
This report summarizes 4 malfunction events, where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In all 4 events, there was a surgical delay of 30 seconds to 5 minutes.Surgeries were successfully completed and no adverse consequences to the patients were reported.
Event or Problem Description
This report summarizes 4 malfunction events, where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In all 4 events, there was a surgical delay of 30 seconds to 5 minutes.Surgeries were successfully completed and no adverse consequences to the patients were reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Corrected data: d2: common device name has been updated from 'posterior cervical screw system' to 'orthopedic manual surgical instrument.' corrected data: h6: method codes have been populated.Additional information and device evaluation: two (2) of the four (4) complaint devices were returned for evaluation (lot gmhc manufactured 03/07/2018 and lot ghec manufactured 01/31/2018).Visual inspection: the device shows signs of slight wear on the distal tip.Functional inspection: functional analysis was performed on the inserter, both hexalobe features on the inserter and the screw were aligned, and were able to engage without any restrictions.An interference was observed between the rectangle inserter head and the screw tulip, during disengagement.The interference was only seen when torque was applied to the system and was sporadic.Hence, this issue could not be consistently replicated.Device and complaint history records were reviewed, and three (3) similar complaints were identified.No relevant manufacturing issues were identified as all units met specifications.Two (2) of the four (4) complaint devices were not returned for evaluation (lots gmhc manufactured 03/07/2018).Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and three (3) similar complaints were identified.No relevant manufacturing issues were identified as all units met specifications.As the instruments were found with jamming issues, it is unclear how and when the incident occurred and what surgical steps were taken during previous surgeries.Inserting the screw with more force than normal, on a bone, can compound torsional forces at the screw/inserter interface, compromising the insertion feature of the screw head.As mentioned in the product ifu, to fully seat the inserter into the screw-head, the inserter has to be completely aligned with the screw.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface, reduce torque overloading, and reduce failures as reported.

• Brand Name: SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9649862
• Report Number: 3004774118-2020-00015
• Device Sequence Number: 380099
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: Health Professional
• Device Catalogue Number: 7601-90003
• Device Lot Number: GMHC, GHEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 01/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1