MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DOUBLE-SIDED TRIAL SPACER LORDOTIC 9MM/10MM HEIGHT; TEMPLATE

Model Number	03.841.009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
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
It was reported that during c5-c7 anterior cervical discectomy and fusion (acdf) on (b)(6) 2019, the end of a double-sided trial spacer lordotic broke off when the surgeon was removing it.The piece that broke off landed on the floor.It was a clean break outside of the wound.There was no surgical delay.There was no harm to the patient.This report is for double-sided trial spacer.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.A device history record (dhr) review was conducted: part number: 03.841.009, lot number: t171321, manufacturing site: tuttlingen, release to warehouse date: 29-oct-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.A product investigation was conducted.Visual inspection: the double-sided trial spacer lordotic 9mm/10mm height (p/n 03.841.009 lot t171321) was received with the large 10l trial spacer broken off from the shaft, at the location of the laser weld.No other issues were identified with the returned components of the device.Device failure/defect was identified.Dimensional inspection: a - non-threaded shaft diameter, adjacent to laser weld was measured dimension: and found to be conforming document/specification review: the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the double-sided trial spacer lordotic 9mm/10mm height (p/n 03.841.009 lot t171321) as the large 10l trial spacer was broken off from the shaft, at the location of the laser weld.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.

• Brand Name: DOUBLE-SIDED TRIAL SPACER LORDOTIC 9MM/10MM 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: 8734928
• Report Number: 2939274-2019-58852
• Device Sequence Number: 2666489
• Product Code: HWT
• UDI-Device Identifier: 10705034732206
• UDI-Public: (01)10705034732206
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 03.841.009
• Device Catalogue Number: 03.841.009
• Device Lot Number: T171321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1
• Patient Age: 60 YR