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

Model Number	498.807S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review / investigation.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 (b)(6) 2019 the patient underwent a hip procedure to remove a trochanteric reattachment device for it band lengthening procedure due to pain in the area.The procedure and patient outcome were unknown.Concomitant devices: unknown cable (part unknown, lot unknown, quantity unknown), unknown cerclage pin (part unknown, lot unknown, quantity 1), unknown cerclage button (part unknown, lot unknown, quantity 1).This report is for one (1) ti trochanteric reattachment device w/cables / long-sterile.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a hip procedure, a removal of trochanteric reattachment device for it band lengthening procedure.Procedure and patient outcome were unknown.This complaint involves one (1) device.This is 1 of 1 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 : (b)(6) 2019.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/LONG-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: 9125217
• Report Number: 2939274-2019-60914
• Device Sequence Number: 2322885
• Product Code: JDQ
• UDI-Device Identifier: 10886982236982
• UDI-Public: (01)10886982236982
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K001709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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 Model Number: 498.807S
• Device Catalogue Number: 498.807S
• Device Lot Number: P299493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE; UNK - CABLE/WIRE ACCESSORIES; UNK - CABLE/WIRE ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention