MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW; TRAY, SURGICAL, INSTRUMENT

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.Provided in mw5077683: 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.[(b)(4) report mw5077683.Pdf].
Event or Problem Description
This report is against user facility medwatch number mw5077683; a copy is attached.The only information contained in this report is correction or additional information.This report is for a conical extraction screw.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.Additional narrative: a device history record (dhr) review was conducted for part # 387.34, synthes lot # up43380: supplier lot # up43380, release to warehouse date: 31jan2005, supplier: unique instruments: no non-conformance reports (ncrs) were generated during production.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: CONICAL EXTRACTION SCREW
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7683374
• Report Number: 2939274-2018-52857
• Device Sequence Number: 1553486
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention