MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 2.4 MM LCP DISTAL RADIUS VOLAR T-PLATE; BONE PLATE

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

Patient Problems Nerve Damage (1979); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: bai, x.Et al (2017), analysis of the efficacy of t-shaped locking compression plate and distal polyaxial locking compression plate in the treatment of distal radius fractures, international journal of surgery, vol.44 (8), pages 539-543 (china).The aim of this retrospective study is to compare the surgical efficacy of t-shaped locking compression plate and distal polyaxial locking compression plate in the treatment of distal radius fractures.Between december 2011 and november 2015, a total of 118 patients were included in the study.Of these, 60 patients (20 male and 40 female; average age of 65 [42 to 79] years) were treated with t-shaped lcp, and 58 patients (17 male and 41 female; mean age of 68.7 [52-80] years) were treated with distal va-lcp two-column plate (manufacturer: johnson & johnson synthes).The mean follow-up time of t-type locking compression plate group was 26.5 months, the mean follow-up time of variable angle two-column locking compression plate group was 25.6 months.Follow-up termination time: after re-examination of x-ray showing fracture healing or before the fracture healing was ready for admission to remove the internal fixation.The following complications were reported as follows: va-lcp two-column plate group: 1 patient had median nerve injury after operation and completely recovered within 2 months after operation.There were 2 factors that were analyzed: (1) the operation time of the patient was significantly longer, and the tourniquet time was cumulatively used for more than 2 hours during the operation; (2) the patient had severe comminution and collapse of the middle column of the radius.T-type lcp group: 1 patient had median nerve injury after operation and completely recovered within 2 months after operation.There were 2 factors that were analyzed: (1) the operation time of the patient was significantly longer, and the tourniquet time was cumulatively used for more than 2 hours during the operation; (2) the patient had severe comminution and collapse of the middle column of the radius.5 patients had loss of palmar inclination angle during follow-up at 6-12 months after operation, and the main reasons were analyzed as follows: (1) the number of screws for individual fracture fragments; (2) improper postoperative functional exercise, and premature weight-bearing.This report is for an unknown synthes va-lcp two-column distal radius plate/screws and lcp distal radius t-plate constructs.This is report 1 of 2 for complaint (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 unk - constructs: 2.4 mm lcp volar distal radius plate system/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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: 2.4 MM LCP DISTAL RADIUS VOLAR T-PLATE
• Type of Device: BONE PLATE
• 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: 15520579
• MDR Text Key: 300995905
• Report Number: 8030965-2022-07646
• Device Sequence Number: 1
• Product Code: JEY
• 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

• 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: 09/13/2022
• Initial Date FDA Received: 09/30/2022
• 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