MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND

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

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - preformed: chronos: trauma/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.

Event Description

This report is being filed after the review of the following journal article: daghino, w., bistolfi, a., aparato, a., and masse, a.(2019), bioabsorbable implants in foot trauma surgery, injury, vol.50(4), pages s47-s55 (italy).The purpose of this study is to standardize the indications and to suggest guidelines for optimizing the use of bioabsorbable devices in foot trauma surgery.From november 2005 to january 2017, a total of 69 patients were included in the study.These patients were divided into 4 froups; the talar fracture group had an average age of 37.0 years (range 14¿66).One of the patients in this group used a synthetic bone tissue (chronos) to fill a bone gap.The calcaneal fracture group had an average age of 41.9 years (range 19¿66).Implants used were a locking compression plate and screws (synthes).The lisfranc group had an average age of 37.3 years (range 15¿68).4 patients used titanium mini-screws, 2.0 mm and 2.7 mm diameter (synthes).The chopart fracture-dislocation group used were 2.7 mm and 2.4 mm titanium mini-screws (synthes), and a synthetic bone tissue (chronos).The article did not specify which of the devices were being used to capture the following complications: talar fracture group patient 5: an (b)(6) year old patient had osteoarthritis.Patient 6: a (b)(6) year old patient had osteoarthritis.Patient 8: a (b)(6) year old patient had osteoarthritis.Patient 12: a (b)(6) year old patient had osteoarthritis.Calcanear fractures group patient 1: a (b)(6) year old patient had delayed skin closure.Patient 10: a (b)(6) year old patient had had delayed skin closure.Patient 18: a (b)(6) year old patient had had delayed skin closure.Patient 21: a (b)(6) year old patient had osteoarthritis.Patient 29: a (b)(6) year old patient had osteoarthritis.Lisfranc group.Patient 9: a (b)(6) year old patient had loss of correction.Patient 10: a (b)(6) year old patient had delayed skin closure.Patient 11: a (b)(6) year old patient had osteoarthritis.Patient 13: a (b)(6) year old patient had osteoarthritis.Patient 14: a (b)(6) year old patient had delayed skin closure.This report is for an unknown synthes chronos.It captures the reported patient 8: a (b)(6) year old patient who had osteoarthritis.This is report 3 of 10 for (b)(4).Additional devices are captured under linked complaint (b)(4).

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11120365
• MDR Text Key: 226556596
• Report Number: 8030965-2021-00069
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/05/2021
• 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): Required Intervention
• Patient Age: 31 YR