MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI POLYAXIAL HEAD FOR USS POLYAXIAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.607.402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: mni, mnh, kwp, kwq.Device returned.A review of the device history record.Device history lot: part: 04.607.402, lot: 8492302, manufacturing site: (b)(4), release to warehouse date: 18.June 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Investigation summary background: libertas: it was reported on (b)(6) 2020, a implant holder does not function and a titanium polyaxial head was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves two (2) devices.Investigation flow: visual.Visual inspection: the ti polyaxial head for uss polyaxial (p/n: 04.607.402, lot #: 8492302) was received at us cq.Upon visual inspection, no defect can be found.The device was received with its two components separated but was able to be put together with no difficulties.Document/specification review: sm_206800 rev c (current and manufactured) was reviewed.No design issues or discrepancies were identified.Conclusion: the overall complaint was not confirmed for the ti polyaxial head for uss polyaxial (p/n: 04.607.402, lot #: 8492302) as the device has no defect found.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.No design issues were observed during the document/specification review.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
Libertas: it was reported on (b)(6) 2020, a implant holder does not function and a titanium polyaxial head was found to be broken during reverse logistics audit of a returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

• Brand Name: TI POLYAXIAL HEAD FOR USS POLYAXIAL
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9649427
• Report Number: 2939274-2020-00577
• Device Sequence Number: 2923261
• Product Code: NKB
• UDI-Device Identifier: 10705034736655
• UDI-Public: (01)10705034736655
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 04.607.402
• Device Catalogue Number: 04.607.402
• Device Lot Number: 8492302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1