MAUDE Adverse Event Report: SYNTHES USA 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; PLATE, FIXATION, BONE

Catalog Number 02.211.040

Device Problem Dull, Blunt (2407)

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

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Due to the intra-operative issues, the screw was not implanted or explanted during the surgical procedure on (b)(6) 2016.(b)(4) unanticipated change to the treatment plan due to the encountered intra-operative issues.The plate could not be locked into place via locking screws; therefore, adequate fixation was not achieved.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Without a valid lot number, a review of the device history records could not be requested.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

It was reported that a 2.7mm/3.5mm variable angle-locking compression (va-lcp) lateral distal humerus plate would not accept the 2.7mm va locking screws during a procedure to repair a left distal humerus fracture on (b)(6) 2016.The surgeon used a cone drill guide and a drill with 2.0mm drill bit.Measurements were taken and the surgeon manually inserted seven (7) of the appropriate 2.7mm va locking screws.As the locking screws were being advanced into the plate, the screws began spinning and would not lock into the plate.The screw heads appeared to be stripped.The surgeon tried changing the angle, but the locking screws still would not engage the plate hole.Several attempts were made to engage the locking screws with the plate.Eventually, all seven (7) screws were removed incrementally and replaced with approximately four (4) 2.7mm metaphyseal screws (metaphyseal screws do not lock into the plate).The plate remained the same and was not replaced with an alternate.The surgeon left one (1) or two (2) of the 2.7mm va locking screws in the plate, even though they did not lock into the plate.The surgeon was unable to achieve lock fixation in any of the plate holes.It appears that the issue resides with the lateral plate and not the 2.7mm va locking screws as a medial plate was also implanted into which the appropriate locking screws were inserted without incident.There was a thirty (30) to forty-five (45) minute delay in the surgery.Standard x-rays were taken (not related to the issue with plate and screw interaction).The procedure was not completed as intended: the surgeon's treatment plan was to establish lock fixation with the lateral plate.Update (june 7, 2016): based upon the initial assessment of the returned parts, the complained issue seems to involve six (6) stripped screws in addition to the originally reported implanted plate.Concomitant device(s) reported: 2.7mm metaphyseal screw 40mm (part: 02.118.540 / lot: unknown / quantity: 1), 2.7mm metaphyseal screw 44mm (part: 02.118.544 / lot: unknown / quantity: 1), and 2.7mm metaphyseal screw 64mm (part: 02.118.564 / lot: unknown / quantity: 1).This report is 4 of 7 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the screws that were originally reported differ from the actual screws that were received.The screws that were originally reported only included 2.7mm va locking screws in varying lengths and quantity.The screws that were received were 2.7mm va locking screws with an additional part number, different quantities and 2.7mm metaphyseal screws.A total of seven (7) screws were originally reported and expected to be returned for investigation, however, a total of nine (9) screws were returned.One 2.7mm/3.5mm va-lcp lateral distal humerus plate 2h/lt/82mm-med (part number 02.117.902, lot number 7852597) was also reported but was not received for evaluation as it is reported to have remained implanted in the patient.The complaint condition is confirmed as each of the six (6) returned locking screws showed significant deformation of the locking threads on the head of the screw.The majority of the threads had been flattened such that they would no longer properly mate with an intended plate.The returned condition is consistent with the result of excessive insertion force inconsistent with recommended use.However, the root cause cannot be definitively determined without additional information regarding the user technique and specific circumstances at the time of the damage.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The three (3) metaphyseal screws were received intact and in functional condition without an alleged complaint condition.Upon visual inspection there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on this device.A dhr review could not be completed for the returned screws as the lot numbers are unknown.Per the technique guide, the reported plate and screws are both part of the 2.7mm/3.5mm variable angle locking compression plate (va-lcp) elbow system.The plate accepts 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws in the shaft of the plate and 2.7mm va, 2.7mm metaphyseal, 2.7mm locking, 2.7mm cortex, and 2.4mm cortex screw in the head of the plate.A review of the current design drawing was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Per the technique guide, the user is to ¿use the cone-shaped end of the drill guide to drill holes as the desired angle.The cone allows the drill bit a total variation in angulation of 30 degrees.¿ the technique guide also states that it is important to ¿not engage the screw head with the plate hole while inserting with power.Screw engagement and final locking must be done manually with the 1.2 nm torque limiting attachment.¿ during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5738208
• MDR Text Key: 47824275
• Report Number: 2520274-2016-13227
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100776
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 02.118.544 - 2.7MM METAPHYSEAL SCREW 44MM
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 59