MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH CORTSCR Ø3.5 SELF-TAP L28 TI; SCREW,FIXATION,BONE

Catalog Number 404.828

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional classification code: hrs a device history record review was requested.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the device was used in original surgery for proximal humeral fracture on (b)(6) 2017.When the (b)(6) female patient underwent the surgery, the proximal humeral plate was applied.As the patient complained pain on the fractured area, it was found on (b)(6) that a screw (part number unknown) had been backed out of the plate.The backed-out screw and the plate were explanted, and then other implants were implanted.The procedure was completed successfully.The x-rays (date of x-rays unknown), shows the screw migrated.Concomitant device: 1x lockscr ø3.5 self-tap l42 tan , 412-118s / l343717, 1x lockscr ø3.5 self-tap l40 tan, 412-117s / l416285 , 1x lockscr ø3.5 self-tap l38 tan, 412-116s / l295107 , 1x lockscr ø3.5 self-tap l36 tan, 412-115s / l329484 , 1x lockscr ø3.5 self-tap l36 tan, 412-115s / l384891 , 1x lockscr ø3.5 self-tap l32 tan, 412-112s / l186802 , 1x lockscr ø3.5 self-tap l30 tan, 412-111s / l339589 , 1x lockscr ø3.5 self-tap l28 tan, 412-110s / l432454 , 1x lockscr ø3.5 self-tap l26 tan, 412-109s / l347791.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a device history record review was performed for the subject device: part number: 404.828, synthes lot number: l337976, release to warehouse date: 02.Mar.2017, manufacturing site: (b)(4).No ncrs 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 a product development investigation was performed for the subject device: 1x article 404.828 with lot l337976 received and forwarded to manufacturing plant (b)(4) for investigation: one screw was received in context of this complaint.The screw in question related to this manufacturing investigation has scratches and marks on the head, thread and hex-drive recess.The part was received in a no original synthes bag.All relevant dimensions were measured, and have fulfilled the specifications according to the drawing 404_810.All the checked features were inspected accordingly during the manufacturing process.Material: the check of the raw material certificate shows that the used material fulfills the specifications.Dispositions: based on the investigation no deviations were found for the implant screw in question.This screw has fulfilled all specifications according to the drawing 404_810.Therefore, from the manufacturing point of view this complaint is rated as not valid and not confirmed.The screw in question was dimensional checked as well as its material certificate is according to specifications and no issues were found caused by the manufacturing process.Therefore, review to the specific prm and pra line is no applicable.X-ray review did show that a screw had been backed out.Therefore, complaint is confirmed.Replication of the complaint condition via functional test is not possible due to post manufacturing wear consistent with implantation and explantation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CORTSCR Ø3.5 SELF-TAP L28 TI
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7102037
• MDR Text Key: 94343215
• Report Number: 8030965-2017-50476
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819076099
• UDI-Public: (01)07611819076099(10)L337976
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 404.828
• Device Lot Number: L337976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2017
• 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
• Patient Outcome(s): Required Intervention