MAUDE Adverse Event Report: SYNTHES MONUMENT 2.4/2.7MM VA-LCP BENDING PLIER; PLIERS, SURGICAL

Catalog Number 03.211.005

Device Problem Break (1069)

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

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Part 03.211.005, lot 6622480: release to warehouse date: january 20, 2012.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported that a 2.4/2.7mm variable angle (va) - locking compression plate (lcp) bending plier broke during a calcaneal open reduction internal fixation (orif) surgery on (b)(6) 2016.The surgeon was using two pliers to bend a 2.7mm va locking calcaneal plate small 58mm right at the back table when the holding pin in the mouth of the pliers broke.It was a clean break and the holding pin was retrieved.A backup pair of pliers was available to successfully complete the surgery.No surgical delay or patient harm reported.Patient status/outcome was reported as stable.Concomitant devices reported: 2.7mm va locking calcaneal plate small 58mm right (part 02.211.400, lot unknown, quantity 1), 2.4/2.7mm va-lcp bending pliers (part 03.211.005, lot 6622480, quantity 1) this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.One 2.4/2.7mm variable angle locking compression plate (va-lcp) bending plier (part number 03.211.005 / lot number 6622480) was received with the complaint category of ¿broken: broken intraoperatively.¿ one 2.4/2.7mm variable angle locking compression plate (va-lcp) bending plier was returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.A device history record (dhr) review, visual inspection and drawing review were performed as part of this investigation.The device history record review determined that the lot (6622480) was supplied by(b)(4) and released to the warehouse on 20-jan-2012.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The 2.4/2.7mm variable angle locking compression plate (va-lcp) bending plier is mentioned in the 2.7mm va locking calcaneal plating system technique guide and the 2.4mm /2.7mm va- lcp forefoot/midfoot system technique guide.The instrument is used to contour variable angle plates to better accommodate a patient¿s anatomy.Its clover leaf shape design protects the variable angle holes during contouring by aligning the cloverleaf protrusion on the pliers with the cloverleaf design in the plate.Two pliers are required to contour the plate.The device was received with the cloverleaf protrusion on the distal tip of the pliers sheared off.The broken portion was not received.A dent was observed on one side of the distal tip and the distal screw shows scraping.The balance of the returned device is in fair condition, consistent with use, with some markings and signs of wear along the length of the pliers.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.A review of the current design drawing and the bottom distal component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.All dimensional inspections completed with calipers.A definitive root cause could not be determined given the unknown circumstances at the time of the issue.The returned condition is consistent with exposure to high shear forces and cyclic loading which permitted the fracture of cloverleaf protrusion on the distal tip.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4/2.7MM VA-LCP BENDING PLIER
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6022745
• MDR Text Key: 57308049
• Report Number: 1719045-2016-10754
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/22/2016

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: 03.211.005
• Device Lot Number: 6622480
• Other Device ID Number: (01)10886982076038(10)6622480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2016; 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VA LOCKING CALCANEAL PLATE (02.211.400); VA-LCP BENDING PLIERS (03.211.005)
• Patient Age: 73 YR