MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.305S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Date of event is unknown.Additional procode: hwc.Lot number is unknown.Complainant part is not expected to be returned for manufacturer review/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.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 the patient was implanted with a trochanteric fixation nail (tfn) for a left hip, status post fall on (b)(6) 2018.The patient underwent removal of the trochanteric fixation nail due to medial migration of helical blade secondary to fall and was converted to left total hip replacement on (b)(6) 2018.It was unknown if there was a surgical delay.Patient outcome was stable.Concomitant device reported: 11mm/130 deg ti cann troch fixation nail 235mm-sterile (part #: 456.328s, lot #: h446334, quantity: 1); 5.0mm ti locking screw w/t25 stardrive 38mm for im nails (part #: 04.005.528, lot #: unknown, quantity: 1).This report is for a 11.0mm ti helical blade 100mm-sterile.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.Patient height reported as 5¿5¿.Patient age or date of birth not available for reporting.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: 11.0MM TI HELICAL BLADE 100MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7529184
• Report Number: 2939274-2018-52243
• Device Sequence Number: 13956101
• Product Code: HSB
• UDI-Device Identifier: 10886982226723
• UDI-Public: (01)10886982226723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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
• Device Model Number: 456.305S
• Device Catalogue Number: 456.305S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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 Weight: 46