MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI TROCH FIXATION NAIL SCREW/120MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.032.120S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device procode: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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.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 orthopedic procedure.During the procedure, one (1) titanium cannulated trochanteric fixational nail, one (1) titanium cannulated trochanteric fixation nail screw, one (1) titanium locking screw 42mm for intramedullary nails and one (1) titanium locking screw 48mm for intramedullary nails were removed.The titanium cannulated trochanteric fixation nail screw advanced and cut out of the femoral head was painful to the patient and a hardware malfunction.The nail was removed with no issues.Procedure was converted to a total hip arthroplasty on this patient.It is unknown if there was surgical delay.Procedure outcome is unknown with no patient consequence.Concomitant device reported: titanium locking screw 42mm for intramedullary nails (part 458.942, lot unknown, quantity 1), titanium locking screw 48mm for intramedullary nails (part 458.948, lot unknown, quantity 1).This report is for one (1) titanium cannulated trochanteric fixation nail screw.This is report 2 of 2 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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 28-jun-2010, expiration date: 31-may-2020, part number: 04.032.120s, 11.0mm ti troch fixation nail screw/120mm ¿ sterile, lot number: 6415533 (sterile), lot quantity: 12.Work order traveler met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21012, tialnbri13.00, lot number: 6030780, lot quantity: 1,565 lbs.Product traveler met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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: 11.0MM TI TROCH FIXATION NAIL SCREW/120MM - 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: 8551762
• Report Number: 2939274-2019-57664
• Device Sequence Number: 18932560
• Product Code: HSB
• UDI-Device Identifier: 10886982094896
• UDI-Public: (01)10886982094896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 04.032.120S
• Device Catalogue Number: 04.032.120S
• Device Lot Number: 6415533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR