MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC SPREADER; SIZE 24X6 MM, 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5203-90109
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tip of an aleutian an lordotic spreader disengaged during use.The procedure was successfully completed without delay and there was no adverse consequence to the patient.
Event or Problem Description
A physician reported that the tip of an aleutian an lordotic spreader disengaged during use.The procedure was successfully completed without delay and there was no adverse consequence to the patient.
Additional Manufacturer Narrative
G3: aware date has been corrected from (b)(6)2020 to (b)(6) 2020.
Additional Manufacturer Narrative
Visual analysis of the returned device showed that the distal tip of the spreader was disengaged from the main body.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.  complaint history was reviewed and no similar complaints for this lot were identified.  a non-conformance was initiated to investigate the root cause associated with this failure mode.The resulting investigation determined that the spreaders require single-piece construction per their drawings; however, the supplier manufactured the instruments as two-pieces (tip and shaft), welded together.  an urgent medical device recall letter was sent on (b)(6) 2020 to the affected customers, notifying them of the issue, with instructions pertaining to the removal and return of the product to stryker.The event captured in this report occurred (b)(6) 2020, prior to execution of the recall.The event was reported to stryker on (b)(6) 2020.
Event or Problem Description
A physician reported that the tip of an aleutian an lordotic spreader disengaged during use.The procedure was successfully completed without delay and there was no adverse consequence to the patient.

• Brand Name: AN LORDOTIC SPREADER; SIZE 24X6 MM, 6
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10340954
• Report Number: 3004774118-2020-00155
• Device Sequence Number: 11699601
• Product Code: LXH
• UDI-Device Identifier: 10888857108226
• UDI-Public: 10888857108226
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2020

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: 5203-90109
• Device Lot Number: FKWW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 09/28/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/07/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004774118-4/9/20-001-R
• Patient Sequence Number: 1