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

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Malunion of Bone (4529); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: philos plate/screws/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

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: shu, ying et al (2021), philos plate plus oblique insertion of autologous fibula for 2-part proximal humerus fractures with medial column disruption: a retrospective study, geriatric orthopedic surgery & rehabilitation, vol.12 (xx), pages 1-6 (china).The aim of this retrospective study is to assess outcomes of older patients sustaining 2-part phfs with medial column disruption stabilized using this philos plate plus oblique insertion of autologous fibula as a primary procedure.Between january 2012 to december 2019, a total of 112 patients (50 male and 62 female) with a median age of 51.2 years (range, 40-62 years) were included in the study.Surgery was performed using a philos plate (synthes, solothurn, switzerland).Follow-ups occurred 1, 3, 6, and 12 months after surgery and every year thereafter.The median follow-up was 36 months (range: 11.2-43.5 months).The following complications were reported: 8 patients had 12 orthopedic complications which involved loss of reduction (n=3), varus collapse (n=2), aseptic loosening (n=3), mal union (n=1), revision (n=2), and intolerable shoulder pain (n=1).1 patient was revised using a long philos plate and placing autologous sacrum, and the other patient requested a semi-shoulder joint replacement.Revision was attributed to poor bone quality in this study.This report is for an unknown synthes philos plate/screws constructs.This report is for (1) unk - constructs: philos plate/screws.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11978958
• MDR Text Key: 267345613
• Report Number: 8030965-2021-04801
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• 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