MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE/17MM & 19MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Model Number	03.835.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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
It was reported that during a routine incoming inspection of a loaner set on (b)(6) 2019, it was observed that the synfix evolution aiming device was broken.There were no patient and surgical involvement.This report is for a synfix® evolution aiming device.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.H10 additional narrative: e1: phone number provided for reporting.H3 (device evaluated by mfr), h6: investigation summary.Background: it was reported that during a routine incoming inspection of a loaner set on august 19, 2019, it was observed that the synfix evolution aiming device was broken.There were no patient and surgical involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the synfix® evolution aiming device/17mm & 19mm (p/n: 03.835.003) was received at customer quality, and upon visual inspection, the reported condition was not observed.The complaint is not confirmed.Investigation requirements: (28aug2019, (b)(6) product code: 03.835.003, lot#: 9877155, quantity: 1.Us customer quality will conduct initial investigation.Upon visual inspection, reported condition was not observed.Se_507695 zone g4 detail z pocket profile appears to be chipped (02oct2019, (b)(6) upon review of the device, it was observed that the device was not chipped.The sharp segment of the device is a part of product design as evidenced by se_507695 revision k.Dimensional inspection: conclusion: the measuring result does show conformity.Document/ specification review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation conclusion: there was no defect found in this device, and therefore, complaint condition is not confirmed.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.H3 (device evaluated by mfr), h4 (device manufacture date), h6: a review of the device history record.Device history lot.Part: 03.835.003, lot: 9877155, manufacturing site: hägendorf, release to warehouse date: 14.Jun.2016.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: SYNFIX® EVOLUTION AIMING DEVICE/17MM & 19MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9075921
• Report Number: 2939274-2019-60624
• Device Sequence Number: 19452106
• Product Code: OVD
• UDI-Device Identifier: 10705034814094
• UDI-Public: (01)10705034814094
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150673
• 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,Followup
• Report Date (Section B): 08/19/2019

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: 03.835.003
• Device Catalogue Number: 03.835.003
• Device Lot Number: 9877155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1