MAUDE Adverse Event Report: SYNTHES SELZACH 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 04.210.114S

Device Problem Failure to Align (2522)

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

Event Date 07/15/2015

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported a distal humeral fracture surgery was executed.During the operation, the reported variable angle (va) locking screw was not locked and passed through the hole of the second row on the radial side of the reported plate.Then, the surgeon removed the screw once.After the surgeon confirmed the screw and the hole by sight, he tried to lock it again with the same screw by changing the angle and tightening in reversed direction in the tunable mode of the drill.However, it was not locked again so that the screw was removed.As a result, the surgery was finished without using the hole on the second row of the plate.There was five (5) minutes delay in the surgery.No patient harm was reported.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was not implanted/explanted.A review of the device history record for the non-sterile part 04.210.114 lot 7710362 was completed: manufacturing location: (b)(4).Manufacturing date: 07 october 2014.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.An additional device history record review was performed to review the sterilization records of the subject device.The subject device was manufactured, as previously reported, in the us; however it was sterilized, repackaged and assigned a new lot number, date of manufacture and expiration date by synthes (b)(4).Date of manufacture (sterilization) nov 10, 2014, expiration date nov 1, 2024.Device manufacture date nov 10, 2014 is the date the subject device was sterilized and thus, this is the considered the correct date of manufacture.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was completed: the anodize color on the shaft and head threads is stripped.The shaft threads are damaged and are flattened in section below head.There is extensive damage on head threads.The head threads are deformed/flattened.The overall length and material are within specification.The head profile and head thread profile could not be checked due to damage.Since all relevant features could not be checked, this complaint is indeterminate from a manufacturing perspective.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

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: 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CO CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CO CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4946331
• MDR Text Key: 17852462
• Report Number: 1719045-2015-10474
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.210.114S
• Device Lot Number: 9240300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1