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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: two (2) of the three (3) lot numbers were provided as kdjr and hvwe.The third lot is unknown.Two (2) of the three (3 )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 3 malfunction events where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In two (2) of the three (3) events, there was a surgical delay of 15-20 minutes.The third event had an unknown delay time.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.Additional information and device evaluation: two (2) of the three (3) complaint devices were returned for evaluation (lot kdjr manufactured 11/26/2019 and lot hvwe manufactured 01/28/2019).Visual inspection: the devices show few signs of cosmetic wears and scratches.Functional inspection: both hexalobe features on the inserters and the screws were aligned and were able engage without any restrictions.Device and complaint history records were reviewed, and one (1) similar complaint for lot hvwe was identified.No relevant manufacturing issues were identified as all units met specifications.Investigation found no known product issue for the returned devices.One (1) of the three (3) complaint devices was not returned for evaluation (lot unknown) visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history records could not be performed as a valid lot code was not provided and could not be obtained.As the instrument was not returned and reported to have 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.
Event or Problem Description
This report summarizes 3 malfunction events where the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.In two (2) of the three (3) events, there was a surgical delay of 15-20 minutes.The third event had an unknown delay time.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: 10351330
• Report Number: 3004774118-2020-00159
• Device Sequence Number: 19441056
• 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: 3
• 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): 10/30/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1