MAUDE Adverse Event Report: SYNTHES OBERDORF 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; BONE PLATE

Catalog Number 806.004.02S

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device not explanted.Contact phone number: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 24.May 2012.Expiry date: 01.April 2015.No anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: sales representative went to hospital to collect the expired consignment stocks.Sales rep was informed by a nurse that some products were used during surgeries which occurred on (b)(6) 2015.Upon checking the case report, sales representative confirmed that some products used were expired.This is report 2 of 8 for (b)(4).

• Brand Name: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4946674
• MDR Text Key: 23101454
• Report Number: 8030965-2015-11272
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PK062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Catalogue Number: 806.004.02S
• Device Lot Number: 7854849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1