MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number 441.901S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation. Initial reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/ or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the surgical neck fracture with the proximal humeral plate in question. The surgery was completed successfully. After the surgery, the patient visited the hospital for following up on (b)(6) 2021, and the surgeon checked the x-ray, and there was no problem with the progress. The patient visited the hospital again on (b)(6) 2021 reporting pain. The surgeon found that there was a spiral fracture distal to the plate and the surgical neck fracture was not united; it lost its reduction. The surgeon removed the proximal humeral plate and replaced with another implant on (b)(6) 2021. New implants were fixed with a slight displacement of the diaphysis because the nail diameter is as small as 8 millimeters for the medullary cavity. The surgery was completed successfully without any surgical delay. This report is for a philos plate. This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12414461
• MDR Text Key: 272454761
• Report Number: 8030965-2021-07429
• Device Sequence Number: 1
• Product Code: KTW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 441.901S
• Device Lot Number: 98P0564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/02/2021 Patient Sequence Number: 1