MAUDE Adverse Event Report: SYNTHES MEZZOVICO 2.4MM LCP(TM) Y-PLATE 3 HOLES HEAD/7 HOLES SHAFT; PLATE,FIXATION,BONE

Catalog Number 249.669

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device used in a veterinary case - no patient information will be reported.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.(b)(6).Fragments of the subject device have been received and are currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: nov 21, 2014.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.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 reported an event (b)(6) as follows: it was reported that during a veterinary corrective osteotomy tibia procedure on (b)(6) 2017, as the surgeon attempted to bend the locking compression plate (lcp) y-adaption plate with a bending pin, the plate slid and came off.As a result, the cutting thread of the device screw hole was broken and couldn¿t be used.There was no surgical delay reported.Concomitant part: bending pin f/lcp plates 2.4 and 2.7 (part# 329.922 lot# 3697993 / quantity 1).Bending pin f/lcp plates 2.4 and 2.7 (part# 329.922 lot# 8474130 / quantity 1).This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (brand name 2.4mm lcp(tm) y-plate 3 holes head/7 holes shaft, part number 249.669, lot number 9264134).The subject device was returned to the manufacturer with the complaint condition stating that as the surgeon attempted to bend the lcp y-adaption plate with a bending pen, the plate slid and came off.As a result, the thread cutting of the device screw hole was broken, and the device couldn¿t be used.No fragments were generated.Only the two links of the y-head of the plate were received for investigation.There is no etch available on these portions; reportedly they belong to part no.249.669 and lot number 9264134.They were cut of the shaft of the plate with a side cutter as the microscopic investigation shows the typical shear-off signs.There is no indication of a breakage and no fractured surface observed.The valid technical drawing for the device was reviewed showing the entire plate shaft length.The returned device was compared and it was concluded that approximately 50 mm of the device was not received for investigation.Because of the deformation and wear on both link portions all complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The complaint description related to breakage and that no fragments were generated cannot be confirmed.A manufacturing conclusion cannot be presented because of the condition of the product and the received information which is poor.The root cause of this complaint is undeterminable.No manufacturing related issue was identified and/or confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM LCP(TM) Y-PLATE 3 HOLES HEAD/7 HOLES SHAFT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6361420
• MDR Text Key: 68426905
• Report Number: 1000562954-2017-10020
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819156920
• UDI-Public: (01)07611819156920(10)9264134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 249.669
• Device Lot Number: 9264134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 329.922, BENDING PIN FOR 2.4MM LOCKING PLATES; 329.922, BENDING PIN FOR 2.4MM LOCKING PLATES,