MAUDE Adverse Event Report: SYNTHES MONUMENT 1.5MM RAPID RESORB ORBTL FL PLW/BENDING TEMPLATE/35MM-STER; BONE PLATE

Catalog Number 851.691.01S

Device Problems Device Expiration Issue (1216); Labelling, Instructions for Use or Training Problem (1318); Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Original implant date: (b)(6) 2016.Removal of the device and implantation of a titanium product.Not implanted or explanted, neither of these two plates would be utilized in the procedure.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 3/29/2012, expiration date: 05-31-2020, part #: 851.691.01s, lot#: 6913455 (sterile) - 1.5mm rapid resorb orbtl fl pl w/bending template/35mm - sterile.No ncrs were generated during production.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.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 complaint involves two devices.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

An updated device history record review was completed: manufacturing location: (b)(4).Manufacturing date: march 29, 2012.Expiration date: may 31, 2020.Part 851.691.01s, lot 6913455 (sterile): no non-conformance reports were generated during production.Review of the device history record(s) showed 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.Manufacturing location: (b)(4), packaged by - (b)(4).Manufacturing date: september 27, 2011.Expiration date: august 31, 2015.Part 851.542s, lot 2770707 (sterile): no non-conformance reports were generated during production.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.Manufacturing location: monument.Manufacturing date: july 15, 2011.Expiration date: may 31, 2020.Part 329.634s, lot 6694806 (sterile): 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.Sterility documentation was reviewed and determined to be conforming.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.

Manufacturer Narrative

(b)(4) potential risk for infection as a result of a potentially expired sterile device being inserted into a patient.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.As the patient¿s incision had not been closed prior to the removal of the device during the procedure on (b)(6) 2016, the device is not considered to have been 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 2 of 6 for (b)(4).

• Brand Name: 1.5MM RAPID RESORB ORBTL FL PLW/BENDING TEMPLATE/35MM-STER
• Type of Device: BONE PLATE
• 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: 5532884
• MDR Text Key: 41408646
• Report Number: 1719045-2016-10271
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062789
• 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,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• 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: 851.691.01S
• Device Lot Number: 6913455
• 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: 03/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention