MAUDE Adverse Event Report: SYNTHES ELMIRA 2.5MM TI ELASTIC NAIL 440MM-STERILE; PIN,FIXATION,SMOOTH

Catalog Number 475.925S

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight is not provided for reporting.(b)(4).Not explanted, device remained implanted in patient.Device remained implanted in patient and therefore is not expected to be returned for manufacturer review/investigation.Device history record review for part #475.925s, lot #5594809: part mfg.Date: 03oct2007, part exp.Date: 31aug2016.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.5mm ti elastic nail ¿ 440mm sterile part was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 reported that during an initial surgery on (b)(6) 2016 for ¿both bone¿ forearm fracture, a 2.5mm elastic nail was opened and used with an expiration date of august 2016.The device remains implanted in the patient.The expiration date was noticed after the surgeon inserted the nail.The surgeon was informed of the expiration date and it was reported that he chose to keep the nail implanted.It was also reported that since the surgeon felt the packaging was good and the expiration date recent, he felt it was more risk to the patient if he removed the nail.The surgery was completed successfully without delay and the patient reported as stable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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: 2.5MM TI ELASTIC NAIL 440MM-STERILE
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6142184
• MDR Text Key: 61405094
• Report Number: 3003506883-2016-10195
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 475.925S
• Device Lot Number: 5594809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR