MAUDE Adverse Event Report: DEPUY SPINE INC MOD 7MM SHAVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	698325390
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Medwatch form received from fda.Uf/reporter # (b)(4).It was reported during a depuy spine case, 7mm shaver broke in 2 pieces.Both pieces were immediately retrieved and intra-op x-ray was obtained.X-ray read by radiology attending, who confirmed that no foreign body was retained from broken instrument.Radiologist spoke to doctor, x-ray was clear.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).

• Brand Name: MOD 7MM SHAVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8181445
• Report Number: 1526439-2018-51162
• Device Sequence Number: 11158663
• Product Code: LXH
• UDI-Device Identifier: 10705034229652
• UDI-Public: (01)10705034229652
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 698325390
• Device Lot Number: 0807T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1