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

Model Number	279792103
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 instr 2 outer was conducted identifying that lot number gc0013c19 was released in one batch.Batch1: released on may 03, 2019 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that exp 5.5 core instr 2 outer was missing one handle (component # (b)(4)).Additionally the "axel hub" component (# (b)(4)) was broken.The broken axel hub component would allow the handle the come apart from the device.No other defects or damage were noted.A dimensional inspection was not performed due to post manufacturing damage to the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the exp 5.5 core instr 2 outer would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: current and manufactured revisions of drawings were reviewed.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 exp 5.5 core instr 2 outer was missing a component.There was no known patient or hospital involvement.Upon manufacturer investigation, it was determined that the device was broken.This report is for an expedium 5.5 core instrument 2 outer.This is report 1 of 1 for (b)(4).

• Brand Name: EXP 5.5 CORE INSTR 2 OUTER
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14042981
• Report Number: 1526439-2022-00536
• Device Sequence Number: 6301705
• Product Code: FSM
• UDI-Device Identifier: 10705034459875
• UDI-Public: (01)10705034459875
• 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: 279792103
• Device Catalogue Number: 279792103
• Device Lot Number: GC0013C19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2019
• 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
• Patient Sex: Unknown