MAUDE Adverse Event Report: DEPUY SPINE INC EXP 5.5 CORE IMPLANT 2,RODS; TRAY, SURGICAL INSTRUMENT

Model Number	279792122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.A review of the receiving inspection (ri) for exp 5.5 core implant 2,rods was conducted identifying that lot number gc0007e17 was released in a single batch.Batch1: released on june 06, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the exp 5.5 core implant 2,rods was received at us customer quality (cq).Visual inspection of the complaint device, it was observed that one screw and washer were missing from the device.One of the radel foot was observed to be broken and signs of normal wearing from heavy field usage were observed on the device.Dimensional inspection: a dimensional inspection is not relevant for this complaint due to the missing components and post-manufacturing damage.Document/specification review based on the manufactured date of the device, the current and manufactured to revision of drawings were reviewed: -base assembly ti & cocr rods investigation conclusion: this complaint could be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.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
It was reported that during routine incoming inspection of a loaner set on an unknown date, it was observed that the bengal standard rasp caddy was broken.There is no known patient or hospital involvement.Upon manufacturer investigation, it was determined that one of the radel foot was observed to be broken and signs of normal wearing from heavy field usage were observed on the device.This report is for a expedium spine system rod case 5.5.This is report 1 of 1 for (b)(4).

• Brand Name: EXP 5.5 CORE IMPLANT 2,RODS
• Common Device Name: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13261254
• Report Number: 1526439-2022-00094
• Device Sequence Number: 4663495
• Product Code: FSM
• UDI-Device Identifier: 10705034459851
• UDI-Public: (01)10705034459851
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 279792122
• Device Catalogue Number: 279792122
• Device Lot Number: GC0007E17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENGAL STANDARD RASP CADDY
• Patient Sex: Unknown