MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS: CALCANEAL; PLATE, FIXATION, BONE

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

Patient Problems Arthritis (1723); Unspecified Infection (1930); Physical Asymmetry (4573)

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: guo, x., ding, e., cai, y.And wang, s.(20xx), clinical experience of different plate internal fixation methods for complex calcaneal fractures (84 cases report attached) (china).The objective of this study is to investigate the effect of two different internal fixation plates on foot function in patients with complex intr-articular calcaneal fractures.Eight-four patients with complex intra-articular calcaneal fractures were treated from january 2015 to december 2017 the patients were divided into the control group and the observation group randomy with 42 cases each.The control group had 37 males and 5 females, aged 30-62 years while the observation group had 40 males and 2 females, aged 30-64 years.The implants used for the control group was a monoaxial locking plate of the calcaneus (johnson & johnson) while the implants used for the observation group was an i.T.S polyaxial locking plate of the calcaneus (general company).The following complications were reported as follows: control group: (n=3) incision infection, (n=3) loss of reduction, (n=2) traumatic arthritis.A copy of the literature article is being submitted with this medwatch.This report involves one unk - constructs: plate/screws: calcaneal.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 constructs: plate/screws: calcaneal/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 - CONSTRUCTS: PLATE/SCREWS: CALCANEAL
• Type of Device: PLATE, 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: 15494640
• MDR Text Key: 300703756
• Report Number: 8030965-2022-07437
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• Date FDA Received: 09/27/2022
• 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: 09/07/2022
• 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): Required Intervention