MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI ROD 120MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	498.125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record(s) showed that there were no nonconformance's or issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection: the 3.5mm ti rod 120mm (p/n 498.125 lot 6882258) was received by us cq and it was observed that the distal portion on the rod was broken.It is clearly sheared off and thus, the complaint condition is confirmed.The rod was bent as well.Device failure/ defect identified? yes.Dimensional inspection: the outer 3.5 + 0 /- 0.016 mm of the rod got measured.Outer diameter: d = 3.5 +0 /- 0.016, caliper: ca 215p, measured rod diameter = 3.50 mm.Conclusion: the measuring result does show conformity.The design, materials and finishing processes were found to be appropriate for the intended use of this device.Document/ specification review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Complaint confirmed? yes.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) 2019, the 3.5mm titanium rod 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 report is for one (1) 3.5mm ti rod 120mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM TI ROD 120MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9162859
• Report Number: 2939274-2019-61256
• Device Sequence Number: 2164802
• Product Code: NKG
• UDI-Device Identifier: 10705034788968
• UDI-Public: (01)10705034788968
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 498.125
• Device Catalogue Number: 498.125
• Device Lot Number: 6882258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1