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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient name/identifier is not available for reporting.Date the device became loose is unknown.It is unknown when the device was implanted.The device is not expected to return for investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent revision surgery on (b)(6) 2017 due to non-union and loosening of one (1) trochanteric reattachment device.The reattachment device was one unit and included a plate and unknown quantity of cables.The initial surgery to implant the trochanteric reattachment device with cables took place on an unknown date and the device became loose on an unknown date post-operatively.The device was explanted intact on (b)(6) 2017.No complications during the revision surgery were noted.No surgical delay was noted.Procedure was completed successfully.It is unknown what the patient was revised to.Patient was listed stable this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
These dates were incorrectly reported as (b)(6) 2017 in initial medwatch report.The correct date is (b)(6) 2017.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: 7205559
• Report Number: 2939274-2018-50320
• Device Sequence Number: 16389737
• Product Code: JDQ
• UDI-Device Identifier: 10886982236975
• UDI-Public: (01)10886982236975(17)EXPIRATIONUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K001709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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
• Device Model Number: 498.806S
• Device Catalogue Number: 498.806S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 75