MAUDE Adverse Event Report: SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.026

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Additional patient¿s identifier reported as (b)(6).Patient¿s date of birth and weight are not available for reporting.Udi: (b)(4) lot number unknown device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that the patient had underwent an open reduction internal fixation (orif) right hip fracture on (b)(6) 2017.Intra-operatively, the surgeon had inserted the trochanteric fixation nail advanced (tfna) nail implant.Subsequently, at the back table, the scrub technician had difficulty assembling the three (3) part blade insertion instrument system to the helical blade implant.The technician was instructed to remove the sleeve assembly from the other instruments.When the technician disassembled the instruments, it was reported that they contained contaminated tissue and blood inside.Surgeon removed the tfna nail due to the fact that there was not another tfna blade instrument system available in the operating room.However, a tfn set was available.The surgeon was able to implant the patient with a tfn nailing construct.The patient was implanted with one (1) (tfn) trochanteric fixation nail, one (1) helical blade and two (2) distal locking screws.There was a six (6) minute surgical delay.The procedure was completed successfully and patient was reported in stable condition.No additional information is available.This report is for one (1) helical blade/screw coupling screw.This is report 1 of 3 for complaint (b)(4).

• Brand Name: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6784203
• MDR Text Key: 82468478
• Report Number: 9612488-2017-10392
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 90 YR