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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 02/22/2018

Event Type  malfunction  

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 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
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7364594
• MDR Text Key: 103676393
• Report Number: 2939274-2018-51195
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692(17)270430(10)H367885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR