MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Fistula (1862); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: lcp/unknown lot. Part and lot numbers are unknown; udi 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. (b)(4). 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: this report is being filed after the review of the following journal article: kempný t. Et al. (2019), use of medial femoral condyle flap and anterolateral thigh free flap in proximal tibial posttraumatic non-union with multiple anastomosis ¿case report, acta chirurgiae plasticae, vol. 61, pages 1-4 (austria). This study presents a case report of a (b)(6) year-old male patient suffered an intraarticular fracture of proximal tibia and fibula in a motorbike accident, classified as 4c3 ao. An angiography with contrast proved an obstruction of the distal part of popliteal artery caused by fracture bone fragments external compression. An opened fixation with locking compression plate (lcp) on proximal tibia (depuy, synthes) was performed after seven days following the admission. Shortly after the surgery, primary symptoms of compartment syndrome appeared in the region of the distal lower limb which was treated with septal fasciotomy. An x-ray examination performed six months after the initial reconstructive surgery has shown signs of non-union located in the previous fracture line along with a fistula opening on the skin surface. Th e culture from fistula was positive for staphylococcus aureus. The lcp in proximal tibia was removed and a radical debridement six weeks after the final reconstructive procedure, the patient was capable of full range of motion in the knee. This report is for an unknown synthes lcp. This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12232967
• MDR Text Key: 266621402
• Report Number: 8030965-2021-06115
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 07/27/2021 Patient Sequence Number: 1