MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE: CERCLAGE CABLE; WIRE, SURGICAL

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

Event Type  Injury  

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: forch, s.Et al.(2021), a minimally invasive cerclage of the tibia in a modified goetze technique: operative technique and first clinical results, european journal of trauma and emergency surgery, vol.Xx, pages 1-8 ((b)(6)) the purpose of this study was to present the minimally invasive technique for classic steel cerclages which was modified so that it can be used for modern cable cerclages in a soft part saving way.During the period from 01/01/2014 to 06/30/2020, 96 patients with tibial shaft fractures were treated with 113 supplemental cerclages using a 1.7 mm cerclage (ref 298.801.01 depuy synthes companies, oberdorf, (b)(6)).There were 42 females and 54 males with an average age of 51.94 years.The following complications were reported as follows: 10 patients had wound infections: 7 infections were located at the medial malleolus and were unrelated to the inserted cerclage.3 infections affected the whole osteosynthesis: there was one superficial impairment of the wound.Healing over the malleolus medialis and the inserted cerclage, which was treated with debridement and split skin grafting.Implant removal was not necessary.The other 2 deep infections required implant removal.Compartment syndromes occurred two times, 1 directly after the trauma and the other on the second day after treating the tibial fracture with minimally invasive cerclage and plate osteosynthesis on the day of trauma.3 patients complained of local irritation resulting from the cerclage.After fracture healing and consecutive implant removal, such symptoms disappeared.In one case, the nervus peroneus profundus was impaired by the cerclage and a hypaesthesia between the first and second toe as well as weakness of the big toe lifter occurred.After the early removal of the cerclage, the hypaesthesia and the weakness were reversed.This report is for an unknown synthes cerclage.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown cable/wire: cerclage cable/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.(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.

• Brand Name: UNK - CABLE/WIRE: CERCLAGE CABLE
• Type of Device: WIRE, SURGICAL
• 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: 13769474
• MDR Text Key: 291715461
• Report Number: 8030965-2022-01627
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown