MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CAGE INSERTER, M5; DRIVER, PROSTHESIS

Catalog Number 273511300

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Rep reported this complaint to synthes.Reporting a couple damaged instruments and trial that occurred in a case today, (b)(6).Cougar inserter: both cross threaded in case: 273511300, lot: ag2066621; 273511300, lot: ag2066617.Cougar 10mm 5deg small trail: medial lateral trial threads cross threaded 273205110, lot: t0911.It was reported that during an anterior lumbar interbody fusion (alif) at l4-l5 on (b)(6) 2016, the inserter tip stripped.When inserting the second inserter into the trial, the inserter tip stripped and the trial became damaged.No fragments generated.Another set was available and surgery was successfully completed without patient harm.A four minutes surgical delay was reported.Devices and implant are available for return.Sales consultant confirmed no additional information.

Manufacturer Narrative

Two (2) cage inserters (product code: 2735-11-300, lot no: ag2066621, ag2066617) were returned to the complaint handling unit (chu) for evaluation.Visual examination of the returned inserters revealed notable signs of wear and the threads on the inserter are damaged; with the leading thread significantly worn-out.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.With the information provided, a definitive root cause for torn threads on the cage inserter and the small 5 degree trial cannot be determined.However, possible root cause of torn threads may be due to incorrect component positioning or inadequate thread engagement of the inserter into the small trial and inadvertently cross threading.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CAGE INSERTER, M5
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5484364
• MDR Text Key: 39812578
• Report Number: 1526439-2016-10183
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 273511300
• Device Lot Number: AG2066621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1