MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 04.211.016S

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is hwc.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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

Synthes europe reports an event in (b)(6) as follows: it was reported that during a surgery to treat a humeral distal bone fracture on (b)(6) 2016 using a variable angle locking compression plate (va-lcp), two variable angle screws could not be locked after insertion.It was reported that the surgeon started the surgery in accordance with the technical guide.After placing the angle variable sleeve, he inserted one of the reported screws to the plate in question; however, it could not be locked.The surgeon then tried several other screws from the other package; two out of three screws in question could not be locked.It was further reported that the two screws could not be locked even after the surgeon drilled for a while.The surgeon decided not to drill until the end and stopped when the screws were embedded into the plate.It was suggested by an unknown source that the surgeon use the another plate one size long and different screws from an unopened pack but the surgeon decided to leave the two unlocked screws and original as they were, and completed the surgery.There was a 10-minutes surgical delay.No patient harm was reported.This report is 1 of 3 for (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5483219
• MDR Text Key: 39759711
• Report Number: 3000270450-2016-10051
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.016S
• Device Lot Number: 9712694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1