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

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra): evaluation of healthcare outcomes of patients treated with depuy synthes upper extremity plate systems identified in the phd between 2000 and 2023.Complications have been identified as per icd 9 & 10 categorization experienced by the following with corresponding intervention, per plate system: clavicle plates: 4 patients had infection, during index admission.26 patients had mechanical complication, during index admission.13 patients had other complication, during index admission.202 patients had subsequent surgery, 0-3 months post-index.55 patients had nonunion/ malunion, 0-3 months post-index.50 patients had infection, 0-3 months post-index.66 patients had mechanical complication, 0-3 months post-index.109 patients had other complication, 0-3 moths post-index.491 patients had subsequent surgery, 0-12 months post-index.86 patients had had nonunion/ malunion, 0-12 months post-index.54 patients had infection, 0-12 months post-index.79 patients had mechanical complication, 0-12 months post-index.277 patients had other complication, 0-12 months post-index.Proximal humerus plates: 20 patients had infection, during index admission.43 patients had mechanical complication, during index admission.55 patients had other complication, during index admission.452 patients had subsequent surgery, 0-3 months post-index.148 patients had nonunion/ malunion, 0-3 months post-index.160 patients had infection, 0-3 months post-index.221 patients had mechanical complication, 0-3 months post-index.224 patients had other complication, 0-3 months post-index.939 patients had subsequent surgery, 0-12 months post-index.307 patients had nonunion/ malunion, 0-12 months post-index.212 patients had infection, 0-12 months post-index.290 patients had mechanical complication, 0-12 months post-index.417 patients had other complication, 0-12 months post-index.Elbow plates (combined with lcp hook plates): 20 patients had infection, during index admission.57 patients mechanical complication, during index admission.41 patients had other complication, during index admission.433 patients had subsequent surgery, 0-3 months post-index.102 patients had nonunion/ malunion, 0-3 months post-index.191 patients had infection, 0-3 months post-index.150 patients had mechanical complication, 0-3 months post-index.231 patients had other complication, 0-3 months post-index.879 patients had subsequent surgery, 0-12 months post-index.212 patients had nonunion/ malunion, 0-12 months post-index.246 patients had infection, 0-12 months post-index.196 patients had mechanical complication, 0-12 months post-index.457 patients had other complication, 0-12 months post-index.Ulna osteotomy plates: 1 patient had other complication, during index admission.1 patient had nonunion/ malunion, 0-3 months post-index.1 patient had other complication, 0-3 months post-index.6 patients had subsequent surgery, 0-12 months post-index.3 patients had nonunion/ malunion, 0-12 months post-index.4 patients had other complication, 0-12 months post-index.Distal ulna plates: 5 patients had mechanical complication, during index admission.3 patients had other complication, during index admission.26 patients had subsequent surgery, 0-3 months post-index.8 patients had nonunion/ malunion, 0-3 months post-index.6 patients had infection, 0-3 months post-index.5 patients had mechanical complication, 0-3 months post-index.10 patients had other complication, 0-3 months post-index.49 patients had subsequent surgery, 0-12 months post-index.10 patients had nonunion/ malunion, 0-12 months post-index.8 patients had infection, 0-12 months post-index.6 patients had mechanical complication, 0-12 months post-index.26 patients had other complication, 0-12 months post-index.Distal radius plates: 13 patients had infection, during index admission.26 patients had mechanical complication, during index admission.32 patients had other complication, during index admission.284 patients had subsequent surgery, 0-3 months post-index.80 patients had nonunion/ malunion, 0-3 months post-index 91 patients had infection, 0-3 months post-index.70 patients had mechanical complication, 0-3 months post-index.133 patients had other complication, 0-3 months post-index.719 patients had subsequent surgery, 0-12 months post-index.147 patients had nonunion/ malunion, 0-12 months post-index.116 patients had infection, 0-12 months post-index.94 patients had mechanical complication, 0-12 months post-index.348 patients had other complication, 0-12 months post-index.Lcp wrist fusion plates: 1 patient had infection, during index admission.28 patients had mechanical complication, during index admission.35 patients had other complication, during index admission.27 patients had subsequent surgery, 0-3 months post-index.7 patients had nonunion/ malunion, 0-3 months post-index.12 patients had infection, 0-3 months post-index.35 patients had mechanical complication, 0-3 months post-index.47 patients had other complication, 0-3 months post-index.140 patients had subsequent surgery, 0-12 months post-index.14 patients had nonunion/ malunion, 0-12 months post-index.19 patients had infection, 0-12 months post-index.50 patients had mechanical complication, 0-12 months post-index.79 patients had other complication, 0-12 months post-index.Hand and foot plates - hand plates: 2 patients had infection, during index admission.6 patients had mechanical complication, during index admission.7 patients had other complication, during index admission.61 patients had subsequent surgery, 0-3 months post-index.13 patients had nonunion/ malunion, 0-3 months post-index.16 patients had infection, 0-3 months post-index.11 patients had mechanical complication, 0-3 months post-index.27 patients had other complication, 0-3 months post-index.140 patients had subsequent surgery, 0-12 months post-index.29 patients had nonunion/ malunion, 0-12 months post-index.23 patients had infection, 0-12 months post-index.20 patients had mechanical complication, 0-12 months post-index.64 patients had other complication, 0-12 months post-index.Hand and food plates - mini fragment plates: 14 patients had infection, during index admission.15 patients had mechanical complication, during index admission.19 patients had other complication, during index admission.136 patients had subsequent surgery, 0-3 months post-index.54 patients had nonunion/ malunion, 0-3 months post-index.66 patients had infection, 0-3 months post-index.30 patients had mechanical complication, 0-3 months post-index.69 patients had other complication, 0-3 months post-index.383 patients had subsequent surgery, 0-12 months post-index.120 patients had nonunion/ malunion, 0-12 months post-index.88 patients had infection, 0-12 months post-index.51 patients had mechanical complication, 0-12 months post-index.161 patients had other complication, 0-12 months post-index.This report involves one constructs: proximal humerus plate/screws.This is report 4 of 10 for (b)(4).Additional reports related to this study are captured under (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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown constructs: proximal humerus plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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: PROXIMAL HUMERUS PLATE/SCREWS
• 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: 19105904
• MDR Text Key: 340236089
• Report Number: 8030965-2024-05101
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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: 03/27/2024
• 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