MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM ANTERIOR SPINE SYSTEM ANTI-TORQUE STABILIZER; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	287720180
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exp ant ant- torque stabilizer (part # 287720180 / lot # x0609) was received at us cq.Besides normal surface wear, the device showed no signs of damage.The overall complaint was not confirmed for the received exp ant ant- torque stabilizer (part # 287720180 / lot # x0609).No defect was identified after visual and functional inspections.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2020, the final tightener shaft was tapered and became stuck in the counter-torque.The surgeon used a normal shorter tightener to complete the procedure.This report is for one (1) expedium anterior spine system anti-torque stabilizer.This is report 2 of 2 for (b)(4).

• Brand Name: EXPEDIUM ANTERIOR SPINE SYSTEM ANTI-TORQUE STABILIZER
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9921052
• Report Number: 1526439-2020-00812
• Device Sequence Number: 11577698
• Product Code: GEA
• UDI-Device Identifier: 10705034219530
• UDI-Public: (01)10705034219530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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 Model Number: 287720180
• Device Catalogue Number: 287720180
• Device Lot Number: X0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1