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  

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.H10 additional narrative: 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.

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 unk - constructs: proximal humerus plate/screws.This is report 6 of 10 for (b)(4).Additional reports related to this study are captured under (b)(4) and (b)(4).

• 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: 19105917
• MDR Text Key: 340159835
• Report Number: 8030965-2024-05103
• 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