MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DOUBLE-SIDED TRIAL SPACER LORDOTIC 7MM/8MM HEIGHT; TEMPLATE

Model Number	03.841.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, and the product evaluation is in progress.No conclusion can be drawn.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 patient underwent a c5-c7 anterior cervical discectomy and fusion (acdf) using the anterior cervical interbody spacer (acis) instruments and trial.The surgeon inserted the double-sided trial spacer lordotic and impacted it into place at c6-c7.During the removal of the double-sided trial spacer lordotic, the sizer end of the instrument separated from the handle.The surgeon then had to retrieve the double-sided trial spacer lordotic from the patient and proceeded with the procedure.There was two (2) minutes surgical delay.The procedure was completed successfully without incident and with no patient consequence.This report is for one (1) double-sided trial spacer lordotic.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that the patient underwent a c5-c7 anterior cervical discectomy and fusion (acdf) using the anterior cervical interbody spacer (acis) instruments and trial on (b)(6) 2019.
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: h3, h4, h6: a device history record (dhr) review was conducted: part number: 03.841.007, synthes lot number: t127025, release to warehouse date: (b)(6)2015, manufacture site: tuttlingen, part expiration date: n/a, list of nonconformance¿s: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No ncrs were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.H3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned device revealed the short-shaft spacer-threads fractured/broke at the most proximal thread.The laser weld between the short-shaft and spacer also broke.No other damage was noted to the other features or components of the device.The received condition of the device agreed with the complaint description; the complaint was confirmed.The complaint is confirmed.There is no clear indication that the complaint condition occurred due to misuse.Dimensional inspection: the diameter of the broken threaded feature measured and is within the specification.The diameter of the shaft proximal to the broken threaded feature measured and is within specification document/specification review: relevant drawings reviewed.Conclusion: the complaint condition is confirmed.While no definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.H11 corrected data: b3, b5: corrected procedure date.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: DOUBLE-SIDED TRIAL SPACER LORDOTIC 7MM/8MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8383003
• Report Number: 2939274-2019-56760
• Device Sequence Number: 2053943
• Product Code: HWT
• UDI-Device Identifier: 10705034732190
• UDI-Public: (01)10705034732190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 03.841.007
• Device Catalogue Number: 03.841.007
• Device Lot Number: T127025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR