MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Event Description

Device report from synthes reports an event in the (b)(6) as follows: this report is being filed after the review of the following journal article: munk, s.A.Et al (2022), incidence and nonunion rates of tibial fractures in adults with osteogenesis imperfecta: a retrospective cohort study of 402 patients with 42 fractures at an expert clinic, bmc musculoskeletal disorders, vol.23 (1077), pages 1-6 (netherlands).This retrospective, descriptive, observational cohort study aims to summarize the incidence of tibial fractures and nonunions in this population, and to give advice on treatment of tibial fractures in oi.Between january 2008 to february 2020, a total of 34 patients (17 male and 17 female) with mean age of 41 [32;61] years were included in the study.Six participants had more than one tibial fracture over time and were included separately, resulting in a total of 42 fractures.Patients were treated with either plate fixation, intramedullary fixation, screw, or conservatively.The following complications were reported as follows: intramedullary fixation: 1 patient (male; age range at fracture: 18¿24 years) who developed nonunion was a type iii oi distal tibial fracture.As treatment, a rushpin was removed and a titanium elastic nail (ten) was implanted.With no evidence of healing, additional cast immobilization was initiated with no result of bone healing.Since the patient is wheelchair-bound and had little pain, eventually the pseudarthrosis was accepted and the patient uses a brace for support (fig.2).A copy of the literature article is being submitted with this medwatch.This report involves one unk - elastic nails: titanium.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown elastic nails: titanium /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.

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16253116
• MDR Text Key: 308252382
• Report Number: 8030965-2023-01059
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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: 01/09/2023
• Initial Date FDA Received: 01/27/2023
• 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 Sex: Male