MAUDE Adverse Event Report: SYNTHES BETTLACH BLADE/SCREW GUIDE SLEEVE

Catalog Number 03.037.017

Device Problems Off-Label Use (1494); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 07/16/2017

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).The complainant reported that the helical blade inserter was not lined up with blade screw guide as instructed in the technique guide.Instead the surgeon hammered the helical blade inserter into grooves in the blade / screw guide and the grooves were malformed.As a result, helical blade got stuck inside screw guide.This resulted in the surgeon having to insert the blade without the blade screw guide.The blade was inserted too far and required additional surgical intervention.This will be reported as a serious injury and product malfunction, caused by use error.Device history records review was conducted.The report indicates that: part # 03.037.017 and lot # l274027, manufacturing location: (b)(4), manufacturing date: 30.Jan.2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 during an initial tfn-a surgery on (b)(6) 2017, helical blade inserter was not lined up with blade / screw guide instead surgeon hammered the helical blade inserter into grooves in the blade / screw guide and the grooves were malformed.As a result, helical blade got stuck inside screw guide.There is no allegation against helical blade inserter and helical blade.Surgeon was able to remove the helical blade and re-insert the same helical blade without the blade guide.Procedure was completed successfully.There was surgical delay for unknown time period.Intra operative x-rays were taken during initial surgery (not available for review) and surgeon thought that helical blade was inserted okay and he closed the patient and completed the surgery.Post-operatively, x-rays taken on (b)(6) 2017, determined that the surgeon inserted the helical blade too far into the femoral head and has planned revision surgery for (b)(6) 2017 to back out the helical blade a few millimeters.Surgeon backed out the helical blade a few millimeters on (b)(6) 2017.The revision surgery was successful with no delay in procedure and patient is reported as stable post operatively.This complaint involves two devices (blade/screw guide sleeve and helical blade).Concomitant devices reported: helical blade inserter (part # 03.037.024, lot # unknown, quantity # 1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(6) the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

A product investigation was performed.The following devices were received 03-037.017, lot l274027 and 03.037.024, lot t145403.Visual inspection of the 03.037.024 blade inserter indicated the distal tip was galled.Inspection of the 03.037.017, helical blade/screw guide sleeve indicated the red color mark on the lateral section peeled off.This complaint involves two devices (blade/screw guide sleeve and helical blade).The 04.038.310s tfn titanium helical blade was not returned with the other devices.A device history review (dhr), device inspection, functional test and drawing review were performed as part of this investigation.This complaint is confirmed due to the lack of for, fit and function between the 03.037.024 and the 03.037.017 instruments.This complaint was replicated using mating instruments and gaging.No new malfunctions were identified as a result of this investigation.The 03.037.017 blade/screw guide sleeve functions with the 03.037.024 helical blade inserter for trochanteric fixation nail as described in tfn advanced proximal femoral nailing system technique guide.Upon visual inspection, the helical blade inserter was galled on the distal end and would not fit into the blade guide without binding.This complaint is confirmed due to the form, fit and function between the two instruments.Relevant drawing was reviewed to verify the 03.037.024, helical blade inserter instrument met print.The distal tip was measured using calipers and the returned part is acceptable.Relevant drawings for guide sleeve were reviewed.The instrument has an id of (dia.11.1mm).The id was measured using plug gages, set gp32 and the largest pin that would pass through without jamming was dia.10.93mm.Diameter 10.95mm jammed.A new defect was also observed during visual inspection of the helical blade/screw guide sleeve, 03.037.017, the red color mark on the lateral side has peeled off.Appropriate actions have been taken to address this issue of the peeling off of the color coding (red/yellow markings).Helical blade inserter was not lined up with blade / screw guide instead surgeon hammered the helical blade inserter into grooves in the blade / screw guide and the grooves were malformed.As a result, helical blade got stuck inside blade/screw guide sleeve.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

Concomitant devices reported: helical blade inserter (part # 03.037.024, lot # t145483, quantity # 1).

• Brand Name: BLADE/SCREW GUIDE SLEEVE
• Type of Device: GUIDE
• 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: 6755813
• MDR Text Key: 81469934
• Report Number: 9612488-2017-10376
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• UDI-Public: (01)10886982070333(10)L274027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.017
• Device Lot Number: L274027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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: 78 YR