MAUDE Adverse Event Report: SYNTHES BETTLACH 1.5MM RAPID RESORB ORBITAL FLR PLATE 35MM X 35MM-STERILE; BONE PLATE

Catalog Number 851.542S

Device Problem Device Expiration Issue (1216)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are: (b)(6).Patient weight not provided.Device is not distributed in the united states, but is similar to device marketed in the usa.Other udi: (01) gtin unavailable, product made prior to gtin compliance date, (b)(4) is not released in the united states.Device not implanted, (b)(6) 2016 - plates was not utilized in the procedure.Device 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: 16.Sep.2011, expiry date: 01.Aug.2015.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 four devices.This report is 2 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.The device was not implanted or explanted during the surgical procedure on (b)(6) 2016.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

(b)(4).

• Brand Name: 1.5MM RAPID RESORB ORBITAL FLR PLATE 35MM X 35MM-STERILE
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5606485
• MDR Text Key: 43583816
• Report Number: 9612488-2016-10204
• Device Sequence Number: 1
• Product Code: JEY
• 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: 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: 08/01/2015
• Device Catalogue Number: 851.542S
• Device Lot Number: 2770707
• 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: 09/16/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention