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 Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Device is an instrument and is not implanted/explanted.(b)(4).Release to warehouse date: november 14, 2005.No non-conformance reports 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 completed: the distal threads of the device were found to be worn and flattened.Unrelated to the complaint the etch was found to be worn and discolored, the proximal holes were found to be nicked and minor deformation was found on the proximal end of the device.The device could not be functionally tested as the tibial nail was not returned.The complaint was confirmed based on the worn/stripped condition of the threads.The relevant drawings were reviewed during investigation.A dimensional inspection of the distal threads was not performed due to the significant post manufacturing wear/flattening.No definitive root cause was able to be determined.It is likely that over 12 years of wear from use contributed to the complaint condition.No manufacturing or design issues were identified during investigation 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 two (2) extraction screws for tibial nails did not work as intended during a revision surgery on (b)(6) 2017.The patient was originally implanted with an unknown tibial nail and three (3) unknown locking screws on an unknown date.Two (2) extraction device threads would not engage (grip) the unknown tibial nail while the surgeon attempted to remove the unknown tibial.A conical extraction device from a non-synthes nail removal system was used to remove the unknown tibial nail.These events resulted in a thirty (30) minute surgical delay.The procedure was successfully completed.The patient outcome was reported stable.The patient was implanted with a new unknown tibial nail and (3) unknown locking screws.This complaint is linked to (b)(4) that captures the patient¿s serious injuries, (2) broken screws and the revision surgery.Concomitant device: tibial nail (part/lot unknown, quantity 1).(b)(4).

• 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7145633
• MDR Text Key: 96125451
• Report Number: 2939274-2017-50413
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)1412195
• 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
• Report Date: 10/27/2017

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: 1412195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2005
• 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 Age: 24 YR
• Patient Weight: 79