MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; PLATE, FIXATION, BONE

Catalog Number 04.211.014S

Device Problems Difficult to Insert (1316); Connection Problem (2900); Material Deformation (2976)

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Patient id/initials, age/date of birth, gender is unknown.Additional product code: hwc.(b)(4) device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6) sterile part: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: november 04, 2015.Expiry date: october 01, 2025.Non-sterile part: manufacturing location: (b)(4).Manufacturing date: march 28, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that variable angle locking compression plate distal humerus plates (va-lcp dhp) was applied for distal end humerus fracture on (b)(6) 2016.The surgeon proceeded locking the screws to the plates as follows: installed the one-holed plate in medial after placed the lateral plate, inserted a cortical screw at the proximal end, fixation started from the distal end, inserted the 04.211.014s screw at the distal end successfully, then inserted one of the reported screws at the next hole of distal end; however, it was not locked.He then removed it and inserted another reported screw, but it was not locked neither.The lot number of those two (2) screws was the same, and they were different from the one which was successfully locked to the distal end.Eventually the surgeon gave up inserting the screw to the second hole from distal end.There was five (5) minutes surgical delay.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Product investigation summary: two 2.7mm titanium variable angle (va) locking screws (part 04.211.014s / lot 9712693) were received with the complaint category of ¿device interaction: does not fit with other parts.¿ the complaint condition is confirmed.The screws were received with deformation of the threads on the va locking head and the two most proximal threads on the thread shaft.This damaged condition would result in not properly locking with the desired plate.The deformation is consistent with plastic deformation and wear from forces between two threaded components where the threads are not aligned.Giving the unknown circumstances at the time of the issue, a root cause cannot be definitively determined.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The deformation noted is in the form of flattening of the threads and areas of removed anodized layer.This damaged condition would result in not properly locking with the desired plate.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the implants are already damaged and the mating plate was not returned.The balance of each implant is in working condition, showing worn edges consistent with wear from implant.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.The deformation is consistent with plastic deformation and wear from forces between two threaded components where the threads are not aligned.The technique guide states that a drill guide is used for the variable angle holes such that drilling can be done at the nominal angle or at a variable angle within a 30 degree cone around the central axis of the plate hole.When drilling, the tip of the drill guide should remain fully seated in the hole.When inserting the variable angle locking screws, the user should not engage the screw head with the plate hole while inserting with power.Screw engagement and final locking must be done manually with the 1.2nm torque limiting attachment.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.

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
• 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: 5467291
• MDR Text Key: 39649243
• Report Number: 3000270450-2016-10046
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.014S
• Device Lot Number: 9712693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 46