MAUDE Adverse Event Report: MSD BARTLETT MFG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7480111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure: extension on previous posterior lumber fusion levels implanted: t10-l5 it was reported that on (b)(6) 2018, intra-op, the tip on the screwdriver shaft broke off when the driver was engaged into the screw.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis result: visual and microscopic examination of the instrument identified shearing of the lead thread, consistent with incomplete engagement of the thread prior to loading.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 7649972
• Report Number: 1030489-2018-00933
• Device Sequence Number: 184320
• Product Code: LXH
• UDI-Device Identifier: 00885074068633
• UDI-Public: 00885074068633
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 7480111
• Device Lot Number: 612040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1