MAUDE Adverse Event Report: DEPUY SPINE INC CAP INSERTER, SHORT; DRIVER, PROSTHESIS

Model Number	277040710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
It was reported that on (b)(6) 2019, the patient underwent hardware removal due to the surgeon wanted to remove screws as they had been in situ for around 15 years.While removing a monarch 6.25x 5.5 mm screws, there were three (3) instruments broke.A two (2) broken teeth of the cap inserter were retrieved but the broken polyaxial screw tip is still in the patient.The monarch screw was relocked and torqued off, hence the remaining tip of the screw cannot be dislodged.Thus, the surgeon is confident that the broken piece will not migrate at all as it is covered by the same like product.It was made mention that the screws wherein the s1 bone and was unattached to the rod.It was not removed due to solid fusion for 15 years since 2004.All three items tagged with red repair tag.Fragments were generated but it was easily removed.There was a surgical delay of 60 seconds and the procedure was successfully completed.Patient status was unknown.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) devices.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation at manufacturer site.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 at manufacturer site, a physical evaluation will be conducted and a supplemental report filed with the results.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).

• Brand Name: CAP INSERTER, SHORT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8684000
• Report Number: 1526439-2019-51741
• Device Sequence Number: 2232897
• Product Code: HWR
• UDI-Device Identifier: 10705034196886
• UDI-Public: (01)10705034196886
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 05/22/2019

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 Model Number: 277040710
• Device Catalogue Number: 277040710
• Device Lot Number: T0307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/16/2019; 08/06/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/27/2019; 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1