MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient weight is not provided for reporting. Date of postoperative blade cut out is unknown. This report is for one (1) unknown proximal spiral blade. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Implanted in (b)(6) 2017; exact date is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. The (510k#): unknown. 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 report that the patient had original surgery in (b)(6) 2017 for treatment of a humeral fracture. Patient was implanted with one (1) ex humeral nail, one (1) proximal spiral blade, two (2) distal locking screws and one (1) end cap. On an unknown date post-operative, patient presented with a non-union. Also, the nail and blade implant had cut out thru the humerus head bone. On (b)(6) 2017, surgeon removed all implants and revised the patient to a total shoulder replacement. It was reported that no fragments were generated during implant removal. All implants have been retained by the hospital. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Concomitant devices reported: distal locking screw (part # unknown, lot # unknown, quantity 2), end cap (part # unknown, lot # unknown, quantity 1), expert humeral nail (part # unknown, lot # unknown, quantity 1). This report is for one (1) unknown proximal spiral blade. This is report 1 of 1 for complaint (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7165214
• MDR Text Key: 96407949
• Report Number: 2939274-2018-50082
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/04/2018 Patient Sequence Number: 1