MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACF TRIAL SPACER/LORDOTIC 6MM; MISC ORTHO SURGICAL INSTR

Model Number	396.416
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
It was reported that on (b)(6) 2019, an anterior cervical fusion trial spacer was noted to be broken during reverse logistics audit of the returned devices at (b)(6).There was no patient involvement this is report 1 for 1 (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 review of the device history record has been requested.Device history lot part # 396.416.Synthes lot # 4246192.Supplier lot # na.Release to warehouse date: 10 apr 2001.Manufactured by synthes brandywine.No ncr's were generated during production.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation summary background: libertas: it was reported that on september 26, 2019, an anterior cervical fusion trial spacer was noted to be broken during reverse logistics audit of the returned devices at millstone.There was no patient involvement and no additional information is available.This complaint involves one device.Investigation flow: damage.Visual inspection: the acf trial spacer/lordotic 6mm (part # 396.416 lot # 4246192) was received at us cq.The device was missing the pin that connects the shaft/headpiece to the handle.Because the pin was missing, the shaft freely toggles and can be completely removed from the device.There is no fractures or evidence of breakage.Although there is no breakage, the overall complaint is confirmed as the devices easily comes apart due to the missing pin.Dimensional inspection: dimensional inspection was not performed due to conclusive finding of a missing component during visual inspection.Document/specification review: manufacturing record evaluation: the received acf trial spacer/lordotic 6mm (part # 396.416 lot # 4246192) was manufactured at the synthes brandywine site on 10-apr-2001.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the overall complaint was confirmed for the received acf trial spacer/lordotic 6mm (part # 396.416 lot # 4246192) as the device comes apart due to a missing pin.Although no definitive root-cause can be determined, it is possible that the pin came undone and went missing through repetitive use/sterilization cycles over its life cycle (18+ years).There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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: ACF TRIAL SPACER/LORDOTIC 6MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9186409
• Report Number: 2939274-2019-61513
• Device Sequence Number: 2413810
• Product Code: LXH
• UDI-Device Identifier: 10705034777665
• UDI-Public: (01)10705034777665
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 396.416
• Device Catalogue Number: 396.416
• Device Lot Number: 4246192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1