MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Model Number	298.801.01S
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
Occupation: 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 1 of 3 for report (b)(4).
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 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.
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.H4 device history part number: 298.801.01s, 1.7mm cable with crimp 750mm -sterile.Lot number: p309113.Manufacturing location: supplier (b)(4)/ inspected, packaged and released by: (b)(4).Release to warehouse dates: 16-jul-2018 quantity 120 / 26-jul-2018 quantity 119 expiration date: 31-mar-2023.Lot quantity: 239 total (120 and 119).Purchased finished goods travelers met all inspection acceptance criteria.Certificates of conformance supplied by rti surgical dated 09-jul-2018 and 18-jul-2018 were reviewed and determined to be conforming.Sterilization results noted on certificate met defined requirements.Inspection sheets, incoming final inspection, 298if800 rev k met all inspection acceptance criteria.Packaging and labeling were 100% inspected and met all inspection acceptance criteria.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: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• 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: 9316807
• Report Number: 2939274-2019-62135
• Device Sequence Number: 2498048
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K992616
• 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: 03/31/2023
• Device Model Number: 298.801.01S
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P309113
• 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