MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PHILOS 3.5 3HO TI; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 441.901S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed for the subject device: part number: 441.901s.Synthes lot number: l348868.Release to warehouse date: 20.Apr.2017, expiry date: 01.Apr.2027.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 441.901s / l348868 philos 3.5 3ho ti sent to manufacturing plant raron for investigation: stains and scratches are visible on the surface.A dhr review was performed.The following work orders lead to the finished product: semi-finished product: l344237.Work order was printed on march 3th 2017 and released on march 9th 2017.Nothing unusual happened; the full lot (120 parts) was produced and found to be in specification.Finished product: l348868.Work order was printed on march 8 th 2017 and released for sale on april 20th 2017.Nothing unusual happened; the full lot (20 parts) was produced and found to be in specification.Investigation of critical features during production: this complaint is about the thread hole in the shaft part of the plate.The critical feature in regards to the complaint is the thread zero point measurement of the thread hole.The inspection measures the thread zero point and at the same time it is a functional test of the conical thread.Investigation of critical features on complaint part: the critical features were verified on the complaint part.All measurements taken align with the results on the tests and measurements performed during production.All measurements of the measurable features were found to be in specifications.Raw material: the plate is manufactured out of the following raw-material: sheet 3.20mm ticp has / article # 60010275 / lot # 19267.The raw-material certificate is attached in attachment 2.It is found to be in specification.Conclusion: the plate (article # 441.901s (philos 3.5 3lo ti) / lot # l348868) was produce as it should.No abnormality in process was found.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.X-ray review did show that a screw had been backed out.Therefore, complaint is confirmed.The material was determined to be conforming at the time of manufacture based on review of the dhr.Replication of the complaint via functional test was not able to be performed at customer quality (cq) due to post manufacturing wear consistent with implantation and explantation.Drawings were reviewed and no product design issues or discrepancies were observed.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.

Event Description

Device report from synthes europe 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 70-to-80-year-old 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: a 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 report is for 1 unknown screws trauma.This is report 3 of 3 for (b)(4).

• Brand Name: PHILOS 3.5 3HO TI
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7260980
• MDR Text Key: 100051182
• Report Number: 8030965-2018-51012
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819797789
• UDI-Public: (01)07611819797789(17)270401(10)L348868
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011815
• 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
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.901S
• Device Lot Number: L348868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1