MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH J HOOK CONNECTOR ASSY; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	188312003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional procodes: (b)(4).Reporter is a synthes employee.The device history record (dhr) of product code 188312003, lot bdme8t5, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on (b)(6) 2018.Visual inspection: the j hook connector assy was received at us customer quality (cq).Visual inspection of the complaint device showed the set screw component was missing.No damage was observed.Dimensional inspection: a dimensional inspection was not performed due to the definitive finding of a missing component.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the set screw component is missing even though there is no damage observed.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 j hook connector assy was broken.There was no patient involvement.Upon receipt of further information, it was determined that there are two devices.This report is for a j hook connector assy.This is report 2 of 2 for (b)(4).

• Brand Name: J HOOK CONNECTOR ASSY
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10310874
• Report Number: 1526439-2020-01365
• Device Sequence Number: 2309845
• Product Code: NKG
• UDI-Device Identifier: 10705034156828
• UDI-Public: (01)10705034156828
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: 188312003
• Device Catalogue Number: 188312003
• Device Lot Number: BDME8T5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1