MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; WIRE, SURGICAL

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

Patient Problems Cellulitis (1768); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter: reporter is a synthes employee.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.(b)(4).

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: wang f, et l.(2019), the modified anterior ellipsoidal cap titanium cable tension band for comminuted patellar fractures, journal of orthopaedic surgery, volume 27, number 3, page 1-6, (china).The purpose of this study was (1) to describe our modified tension band technique and (2) to assess the outcomes in a series of patients who underwent surgical fixation of patellar fractures using this technique.From october 2015 to december 2017, 25 patients who presented with closed comminuted patellar fractures were included in the study.There were 16 males and 9 females with a mean age of 54 years (range, 18-87 years).These patients underwent open reduction and internal fixation of closed comminuted patellar fractures using the modified tension band technique.All patients were implanted with 2 unknown synthes 2.0-mm titanium k-wires and an unknown synthes 1.0 mm diameter, 750 mm titanium orthropaedic cable system.No casts or braces were necessary after the surgery.The skin sutures were removed 2 weeks after surgery.The mean follow-up was 25 months (range 17¿39 months).Complications were reported as follows.1 patient had moderate discomfort due to soft tissue irritation in the operative knee 2 weeks after surgery; however, pain resolved by the 3-month postoperative visit without intervention.1 patient had mild cellulitis on the incision site by postoperative day 5 and the patient was treated with an oral second-generation cephalosporin antibiotic for 10 days.Sutures were removed 16 days after surgery and there were no signs of infection.This report is for the unknown synthes 2.0-mm titanium k-wires and unknown synthes 1.0 mm diameter, 750 mm titanium orthopaedic cable system.This is 3 of 3 for report (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 - CABLE/WIRE: ORTHOPAEDIC CABLE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9746161
• MDR Text Key: 192690514
• Report Number: 8030965-2020-01351
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention