MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER; CERCLAGE FIXATION

Model Number	498.806S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.(b)(4).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 an unknown date, there was a conversion of previous hip surgery to left hip hemiarthroplasty.The reason for the conversion was still unknown.The procedure outcome and patient status were unknown.This complaint involves three (3) devices.This is 3 of 3 for report (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.Event description updated.Received by manufacturer: date updated.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
The cause for revision was 2 stage infection.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history part number: 498.806s, ti trochanteric reattachment device w/cables/standard-sterile.Lot number: p252359 (sterile).Expiration date: 31-jul-2021.Lot quantity: (b)(4) total (three receipts of 12, 10 and 8).Manufacturing location: supplier- rti surgical/inspected, packaged and released by: monument release to warehouse date: 05-jan-2017.Purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection 498if806 rev f met all inspection acceptance criteria.Certificates of conformance received from rti surgical dated 27-dec-2016 were reviewed and determined to be conforming.Sterility parameters and results provided by rti were reviewed and determined to be conforming.Note: there was no sterility expiration date notated in the certificate of conformance or required by the inspection sheet.Expiration date was notated on the traveler.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9316806
• Report Number: 2939274-2019-62137
• Device Sequence Number: 13604753
• Product Code: JDQ
• UDI-Device Identifier: 10886982236975
• UDI-Public: (01)10886982236975
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K001709
• 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,Followup
• Report Date (Section B): 10/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 498.806S
• Device Catalogue Number: 498.806S
• Device Lot Number: P252359
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 12/17/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/10/2019; 12/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention