MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI ROD 400MM; ORTHOSIS, SPINAL PEDICLE

Model Number	498.294
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
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 that on (b)(6) 2019, two (2) 6.0mm hard rod was discovered 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.This is 2 of 2 for report (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.Investigation flow: damage visual inspection: the 6.0mm ti rod 400mm (p/n 498.294 s/n (b)(4)) was received at customer quality.The tip of the returned rod¿s cross-section showed evidence that the rod was cut and not broken.The observed stress marks at the cross-section were consistent with the rod being cut by a tool as the stress marks indicate a heavy force was applied to the two sides of the rod.The use of a cutting tool would yield a similar stress pattern.Moreover, the cut cross-section was very flat, there was no evidence of concavity or surface deviation which would be expected of rod breakage/fracture.It is normal procedure to cut/size/shape the rods based on patient needs.The returned rod is consistent with a cut rod, not a broken rod.The overall complaint is not confirmed.Device failure/ defect identified? no; based on the surface condition at the site of material separation, the rod was cut and not broken.Dimensional inspection: conclusion: the measuring result does show conformity.Document/ specification review: the following drawing(s) was reviewed.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Complaint confirmed? no.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is not confirmed and 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 history lot part: 498.294, lot: 3631228, manufacturing site: (b)(4), release to warehouse date: dec 02, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 6.0MM TI ROD 400MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9364536
• Report Number: 2939274-2019-62350
• Device Sequence Number: 2209229
• Product Code: NKB
• UDI-Device Identifier: 10705034789972
• UDI-Public: (01)10705034789972
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 498.294
• Device Catalogue Number: 498.294
• Device Lot Number: 3631228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/27/2019
• Patient Sequence Number: 1