MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: CONDYLAR PLATE, FIXATION, BONE

Catalog Number UNK - PLATES: CONDYLAR

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/12/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2011, the patient underwent the tka surgery at another hospital. After surgery, on unknown date, the supracondylar fracture occurred, and the revision surgery was performed with the plate in question. After revision surgery, non-union occurred. The second revision surgery will be performed on (b)(6) 2022, for treatment of non-union. In the second revision surgery, a retrograde nail will be inserted from intercondyle. No further information is available. Unk - nail (part# unknown; lot# unknown; quantity: unknown). This complaint involves one (1) device unk - plates: condylar. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4). Additional narrative: 510k: this report is for an unknown distal condylar plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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.

• Brand Name: UNK - PLATES: CONDYLAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14054110
• MDR Text Key: 288885817
• Report Number: 8030965-2022-02315
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK - PLATES: CONDYLAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/08/2022 Patient Sequence Number: 1

Treatment

UNK - NAIL