MAUDE Adverse Event Report: DEPUY SYNTHES SPINE POLY SCW DRIVER SHFT, CANNULTD; DRIVER, PROSTHESIS

Catalog Number 286720000

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be submitted 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

There are 100+ items placed on dc orthokit quarantine due to breakages, functional tests failures.Thirty eight pertain to depuy spine products.In all cases no data available if any injures or adverse events.No information about surgery, delays, patient related data.Only product code/lot description and breakage definition is available.(b)(4).

Manufacturer Narrative

Visual examination of the returned device revealed the distal tip was broken.Torn threads and rust spots were also noted.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.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the breakage/damage cannot be positively determined.However, a potential root cause may be wear and tear on the instruments and/or instrument being subjected to a higher than anticipated stress during use resulting in fracture.The rust spotting and discoloration may be attributed to extensive usage and cleaning over a long period.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 were found, 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: POLY SCW DRIVER SHFT, CANNULTD
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6656925
• MDR Text Key: 78151486
• Report Number: 1526439-2017-10488
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286720000
• Device Lot Number: UI0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1