MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.290S

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  Injury  

Manufacturer Narrative

Patient age, dob & weight not provided for reporting. Event date: unknown - 2018. Implant date: the original surgery was approximately two years ago on an unknown date and was done out of state. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate. 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 underwent hardware removal of a right tfn-advanced proximal femoral nailing system (tfna) on (b)(6) 2018 due to femoral head cutout and non-union. The surgeon was converting to a total hip. The initial surgery was approximately two years ago and was done out of state. During the procedure the surgeon removed one (1) 11mm/130 deg ti cann tfna 170mm, one (1) tfna helical blade 90mm, and an unknown 5. 0mm screw. The implants were removed without incident. There is no additional information. Concomitant device(s) reported: cannulated nail (part #: 04. 037. 142s, lot #: h069675, qty: 1). Locking screw (part #: unknown, lot #: unknown, qty: 1). This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis. Reported: device history lot part number: 04. 038. 290s, lot number: h069675, part manufacture date: n/a, manufacturing location: n/a, part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira. Device history review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira. Investigation summary: product complaint product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. Remove expiration date from previous mw. Synthes manufacturing location reported for the subject device. Complainant part is not expected to be returned for manufacturer review/investigation. If additional information is made available, the investigation will be updated as applicable.

Event Description

Update: 4/4/2018: concomitant device lot # is: h071282.

• Brand Name: TFNA HELICAL BLADE 90MM 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7412729
• MDR Text Key: 104894222
• Report Number: 2939274-2018-51558
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2018
• Device Model Number: 04.038.290S
• Device Catalogue Number: 04.038.290S
• 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: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/10/2018 Patient Sequence Number: 1