MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.015S

Device Problems Break (1069); Crack (1135)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 the patient underwent revision surgery for one (1) tfna blade and one (1) tfna femoral nail due to pain. After removing the blade, the surgeon noticed the nail was cracked but not completely broken. However, during the removal process the nail completely fractured into two (2) pieces. The implant was initially inserted in (b)(6) 2020. There is no further information available. Concomitant devices reported: unknown tfna end cap (part# unknown, lot# unknown, quantity 1). Locking screw l44 f/nails tan light green (part# 04. 005. 534, lot# l761200, quantity 1). This report is for one (1) 10mm/125 deg ti cann tfna 235mm/left - sterile. This is report 1 of 2 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 235MM/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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10514038
• MDR Text Key: 206350217
• Report Number: 2939274-2020-04020
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.037.015S
• Device Lot Number: H612163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/10/2020 Patient Sequence Number: 1

Treatment

LOCKSCR 5 L44 F/NAILS TAN LIGHT GREEN; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE