MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CMF; SCREW, FIXATION, BONE

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075); Non-union Bone Fracture (2369); Cardiovascular Insufficiency (4445)

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for unknown screws: cmf/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.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

This report is being filed after the review of the following journal article: day k.E, et al(2014), hardware removal after osseous free flap reconstruction, otolaryngology- head and neck surgery: vol.150(1), pages 40-46 (usa).The purpose of this study is to identify potential risk factors, including ostecutaneous radial forearm versus fibular flap, for need for removal and to describe the fate of implanted hardware.From september 2004 to october 2012, a total of 213 patients who underwent mandibular defect reconstruction with either a radial or fibular vascularized osseous flap.In the collective patient population, the majority were caucasian (78%) and male (68%), mean age was 58.8 years (range, 18-97 years).Approximately 81% of patients were determined to be asa class 1 or 2 preoperatively, and 76% of patients were current or former tobacco users at the time of presentation.Average length of stay was 8.5 days (sd=3.55, range, 2-24 days).Of the 213 flaps evaluated, overall exposure (external or intraoral) rate was 19% (n=41; 21 patients in the non-hardware removal group and 20 in the hardware removal group).It was found that 34 (16%) patients incurred a hardware removal.Clinical and surgical factors were then assessed between removal group and non removal group.Surgical fixation was performed in the following way: mandibular hardware was bent intraoperatively to obtain appropriate contour, and bicortical locking screws were used on the native mandible and monocortical locking screws on the bone flap.At least 3 screws were placed on the native mandible and 2 placed on each segment of the bone flap.Synthes (west chester, pennsylvania) mandibular hardware was used with rare exception throughout the study period.Other surgery-related information such as type of osteocutaneous free flap (radius or fibula), flap location (anterior, lateral or both), type of plate used (2.0mm, 2.4mm, other or not recorded).Reported complications: wound infection or fistula formation, free flap vascular insufficiency, 20 cases of exposure, 17 cases of infection, 7 cases of pain, 6 cases of malunion.This report is for unk - screws: cmf.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15797676
• MDR Text Key: 303643758
• Report Number: 8030965-2022-09810
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 10/24/2022
• 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
• Patient Outcome(s): Other