MAUDE Adverse Event Report: SYNTHES MONUMENT BENDING TEMPLATE-STER F/1.5MM RESORB ORBITAL FLOOR PL 35MM

Catalog Number 329.634S

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Sedation (2368); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Not implanted: (b)(6) 2016 - plates was not utilized in the procedure.Not explanted; device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).These events resulted in removal of the device and implantation of a titanium product, which caused a 30 minute surgical delay, prolonging the patient's exposure to anesthesia, and may lead to increased risk of infection.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 15-jul-2011, expiration date: 31-may-2020, part #: 329.634s, lot#: 6694806 (sterile) - bending template-stwe f/1.5mm resorb orbital floor pl 35mm.(b)(4) was created on 16-jun-2011 for "parts are scrached." 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.Scn 7752, ¿sterility documentation was reviewed and determined to be conforming.¿ 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 expiration dates printed on the labels of the inner pouches of two rapid resorb orbital floor plates do not match the dates printed on the outer packaging of the rapid resorb orbital floor plates with bending template.The inner pouch packages have an expiration date of august 2015.The outer packaging has an expiration date of may 2020.This was identified when one of the plates was opened during a left orbital floor blowout fracture repair on (b)(6) 2016.The plate and included template were placed into a warming bath for molding on the sterile field and were placed into the patient's orbital socket for a test fit.It was then realized that the product packaging included an expired expiration date.The surgical field was considered contaminated, and the patient is considered at risk of infection.Another orbital floor plate package bearing the same part and lot combination was opened as a comparator.Again, the same expired expiration date was identified on the inner pouch.It was decided that neither of these two plates would be utilized in the procedure.A titanium orbital plate and screws from a craniomaxillofacial (cmf) tray were implanted.There was a reported 30 minute surgical delay.The procedure was completed without further incident and with the patient in stable condition.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

Product investigation summary: it was reported that the expiration dates printed on the labels of the inner pouches of two rapid resorb orbital floor plates do not match the dates printed on the outer packaging of the rapid resorb orbital floor plates with bending template.The inner pouch packages have an expiration date of august, 2015; the outer packaging has an expiration date of may, 2020.Six devices were received with a complaint category "labeling: content." this complaint is confirmed as visual inspection shows that the inner pouch label expiry dates do not match the outer packaging label expiry dates.Whether this complaint can be replicated at customer quality (cq) is not applicable.A delivery stop and screening notice have been initiated in order to address this concern.The awareness date of the reported event was march 15, 2016.Notification/awareness of this particular part was april 6, 2016.Device is an instrument and is not implanted or explanted.Device 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

This report is 6 of 6 for (b)(4).

• Brand Name: BENDING TEMPLATE-STER F/1.5MM RESORB ORBITAL FLOOR PL 35MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5606484
• MDR Text Key: 43583670
• Report Number: 1719045-2016-10354
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 329.634S
• Device Lot Number: 6694806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2011
• 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 Outcome(s): Required Intervention