MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.161S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient dob and weight not provided for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: dhr review for: manufacturing location: (b)(4), manufacturing date: 23-may-2017, expiration date: 30-apr-2027.Part #: 04.037.161s, lot#: h367885 (sterile) - 11 mm/130 deg ti cann tfna 400 mm / left - sterile.Quantity 5.Component parts reviewed: part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot ¿ l392855.Part 04.037.912.4 - wave spring, shim ended bp-55 lot ¿ h089457.Part 04.037.912.3 - tfna lock drive bp-58 lot ¿ h351646.Part 21127 - raw material lot bp-80 lot ¿ h189289.Raw material for titanium received from (b)(4).Certified test report received from (b)(4) meet specification.Certificate of test for chemical composition of titanium ingot meet specification.Raw material receiving/putaway checklist meet requirements.
Event or Problem Description
It was reported that during original procedure of orif left hip on (b)(6) 2018, surgeon was trying to connect the nail to insertion handle and he cross threaded connecting screw into nail which caused nail not to connect properly to insertion handle.The 3.2 mm guide wire was sitting too low or too high in the nail.Upon using 6/9 stepped drill bit, the drill bit tip hit inside of the nail causing tip of the drill bit to break off into the patient into multiple pieces.Fragments were embedded in patient.Surgeon did not attempted to retrieve the fragments.Upon of insertion of helical blade, the guide wire advanced through the femoral head.Due to this occurring, the surgeon took out the helical blade, took out the guide wire and re inserted the helical blade without a guide wire.There was 2 min delay in procedure.Procedure was completed successfully and patient was reported as stable.Concomitant devices reported: insertion handle (part # - 03.037.012, lot # unknown, qty ¿ 1), helical blade (part # 04.038.310s, lot # h379767, qty ¿ 1).This complaint involves four devices (connecting screw, nail, drill bit, guide wire).This report is 4 of 4 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - 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: 7364594
• Report Number: 2939274-2018-51195
• Device Sequence Number: 1232987
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692(17)270430(10)H367885
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/22/2018
• 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