MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.5MM TI HARD ROD 400MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	04.633.294
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, the rod was discovered as broken during inspection.There was no patient involvement and no additional information is available.This report is for one (1) 5.5mm ti hard rod 400mm this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part: 04.633.294, lot: 754805, manufacturing site: mezzovico, supplier: n/a, release to warehouse date: august 25, 2011, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: 5.5MM TI HARD ROD 400MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: brandee sandy ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 13733788
• Report Number: 2939274-2022-00840
• Device Sequence Number: 14588722
• Product Code: NKB
• UDI-Device Identifier: 10705034746555
• UDI-Public: (01)10705034746555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PRE AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.633.294
• Device Catalogue Number: 04.633.294
• Device Lot Number: 7548051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown