MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: the defect was noted during surgery on (b)(6) 2017.It is unknown when the defect occurred.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 was originally implanted on an unknown date approximately one year ago.The patient underwent a hardware removal surgery on (b)(6) 2017 to remove a tibial nail and four unknown screws because the patient had pain.During the removal surgery, the extraction screw for the tibial nail was noted to have a thread defect.The part was not used.The nail was extracted without the component.There was no surgical delay.No harm was reported to the patient.The procedure was completed successfully.The patient outcome was reported as stable.This complaint captures the incident occurred during the revision surgery.(b)(4) captures the post-operative pain and the need of revision surgery.Concomitant devices reported: tibial nail (part# unknown, lot# unknown, quantity 1).Screws (part# unknown, lot# unknown, quantity 4).This report is for one (1) extraction screw for ti femoral and tibial nails.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: lot and udi number.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 device history record (dhr) review was performed for part no.: 357.133, lot no.: l026842: manufacturing location: (b)(4), release to warehouse date: 18.Oct.2016: no non-conformance reports (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.A product investigation was performed.The extraction screw for ti femoral and tibial nails (357.133 lot 9204815 mfg 03feb2015) is a common trauma instrument, noted in 11 nail system technique guides including: titanium cannulated tibial nails, adolescent lateral entry femoral nail and titanium retrograde/antegrade femoral nail.In each instance, the extraction screw is available if implant removal is desired.The extraction screw is threaded into the implanted nail and a hammer guide is attached to the extraction screw allowing for implant removal with light hammer blows.The returned extraction screw was examined and the complaint condition was able to be confirmed as the distal threaded tip was found to be deformed.The complaint condition was unable to be replicated due to post-manufacturing damage.No definitive root cause could be determined; the failure mode is typically associated with attempted off-axis insertion leading to thread deformation.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.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.

• Brand Name: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7164258
• MDR Text Key: 96608974
• Report Number: 2939274-2018-50072
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)LOT#UNKNOWN
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: L026842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/16/2018; 01/23/2018
• Supplement Dates FDA Received: 01/17/2018; 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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