MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 85MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.302
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
It is unknown when patient¿s pain began.Additional procode: hwc.Date of implantation is unknown date two and half years prior to explantation.Complainant part is not expected to be returned for manufacturer review/investigation.Part: 456.302; lot: 9899047; date of manufacture: september 14, 2015; place of manufacture: (b)(4); nonconformance noted: n/a; description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0mm titanium (ti) helical blade 85mm non-sterile product was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.(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) 2018, the patient underwent a removal of titanium (ti) trochanteric fixation nail (tfn) helical blade due to pain.The patient was originally implanted two and a half years ago.The helical blade was removed as planned with no complications.It was not replaced with a new blade.The tfn nail and the distal intramedullary locking bolt remained implanted.The procedure was completed successfully with no surgical delay reported.Current patient status is unknown.This report is for a 11.0mm ti helical blade 85mm.This is report 1 of 3 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 85MM
• 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: 7624914
• Report Number: 2939274-2018-52576
• Device Sequence Number: 16526259
• Product Code: HSB
• UDI-Device Identifier: 10886982226655
• UDI-Public: (01)10886982226655
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K011857
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: 456.302
• Device Catalogue Number: 456.302
• Device Lot Number: 9899047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/21/2018
• 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: 68