MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP OLECRANON PL 4H/RT/116MM-STER; PLATE,FIXATION,BONE

Catalog Number 04.107.204S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed 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 reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, the patient underwent for a surgery.The hospital had ordered va-lcp olecranon plate (4 holes) as a backup of the tea treatment.The sales rep had told the agency in advance that the plate was out of stock in (b)(4), but the agency failed to tell the surgeon about it.When the sales rep entered the operating room in the middle of the surgery (before setting a plate), he told the surgeon that the olecranon plate was out of stock and he couldn't arrange it.Originally, the surgeon wanted to use the olecranon plate, but there was no choice but to use other plate.Eventually, a proximal urna plate (8 holes) were cut and used in the surgery.The surgery was completed successfully.No further information is available.This complaint involves one (1) device.This report is for (1) 2.7mm/3.5mm ti va-lcp olecranon pl 4h/rt/116mm-ster.This report is 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP OLECRANON PL 4H/RT/116MM-STER
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11987702
• MDR Text Key: 256034285
• Report Number: 8030965-2021-04874
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504646
• UDI-Public: (01)07611819504646
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.107.204S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1