MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI TROCH FIXATION NAIL SCREW/105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.032.105S
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
Additional narrative: (b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.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) 2018, the patient underwent hardware removal due to infection of the hip.During the removal, the titanium trochanteric fixation nail screw, titanium cannulated trochanteric fixation nail, and titanium locking screw with t25 stardrive were removed.Procedure outcome and patient status are unknown.This report is for one (1) titanium trochanteric fixation nail screw.This is report 1 of 3 for (b)(4).

• Brand Name: 11.0MM TI TROCH FIXATION NAIL SCREW/105MM - 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: 8232420
• Report Number: 2939274-2019-55761
• Device Sequence Number: 950638
• Product Code: HSB
• UDI-Device Identifier: 10886982094865
• UDI-Public: (01)10886982094865
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K092646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.032.105S
• Device Catalogue Number: 04.032.105S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 62