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	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.2 of the 10 devices have been returned and are pending evaluation.
Event or Problem Description
This report summarizes 10 malfunction events, where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In 8 of the 10 events, there was a surgical delay of 2-5 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: d.2.Common device name has been updated from 'posterior cervical screw system' to 'orthopedic manual surgical instrument.' additional information and device evaluation: two (2) of the ten (10 ) complaint devices were returned for evaluation (lot hvwe manufactured 01/28/2019 and lot hfyp manufactured 09/21/2018).Visual inspection: the device shows signs of slight wear on the distal tip.Functional inspection: the tip of the inserter was not engaging properly on the screw head.When engaged, the inserter had difficulty during disengagement.The interference was observed between the oval inserter head and the screw tulip, during disengagement.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified for the lots.Eight (8) of the ten (10 ) complaint devices were not returned for evaluation: visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.In conclusion, as a result, the root cause could not be confirmed, despite the replication seen during functional test.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.
Event or Problem Description
This report summarizes noe 10 noe malfunction events, where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In 8 of the 10 events, there was a surgical delay of 2-5 minutes, surgeries were successfully completed, and no adverse consequences to the patients were 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: 9257533
• Report Number: 3004774118-2019-00133
• Device Sequence Number: 19765824
• 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: 10
• 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): 07/22/2020

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: HVWE; HFYP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1