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

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

Patient Problems Abscess (1690); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown calcaneal plate and screw constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: wansbrough g., cavanagh p., kelly a., (2007) injuries associated with calcaneal fractures¿an mri assessment, foot and ankle surgery volume 13, pages 109¿115(united kingdom) this study aims to (1) assess the associated injuries around the foot and ankle seen on mri after operatively treated calcaneal fracture and correlate them with the clinical outcome;(2) assess the suitability of mri in reviewing fracture reduction and the position of titanium metalwork.Between april 2000 and june 2003, 27 unilateral isolated closed intra-articular fractures of the calcaneum were treated (20 male, 7 female, mean age 45, range 7¿ 75).After plain x-ray series and ct scanning, six with minimal displacement were managed conservatively (mean age 40, range 7¿68).Once the soft tissue swelling had settled, the remainder (mean age 46, range 19¿75) were treated with orif using titanium alloy calcaneal plates and screws (stratec medical, switzerland).One patient was excluded because the use of a stainless-steel plate prevented adequate mr imaging.In 19 patients, mri scans were undertaken at (mean) 7.5 weeks to assess the technical aspects of reduction and fixation, and identify associated soft tissue and tarsal injuries.The following complications were reported as follows: a case of a (b)(6) had mild talar edema.A case of a (b)(6) had mild talar edema, persisting subcutaneous oedema.A case of (b)(6) had persisting subcutaneous oedema.A case of a (b)(6) had mild edema, persisting subcutaneous oedema.A case of a (b)(6) had mild edema.A case of a (b)(6) had severe edema.Screw artefact degraded the mr images sufficiently to prevent the exclusion of misplaced screws with this modality alone.A case of a (b)(6) had severe edema.Minor persistent depression of the anterior facet was reported >2mm.A case of a (b)(6) minor persistent depression of the anterior facet was reported >2mm.A case of a (b)(6) had mild edema.Minor persistent depression of the anterior facet was reported >2mm.A case of a (b)(6) had mild edema.A case of a (b)(6) had mild edema, persisting subcutaneous oedema a case of a (b)(6) had mild edema.Screw artefact degraded the mr images sufficiently to prevent the exclusion of misplaced screws with this modality alone.A case of a (b)(6) had mild edema.A case of a (b)(6) had mild edema.A case of a (b)(6) had persisting subcutaneous oedema.In one patient coronal ti weighted images appeared to confirm the presence of a screw in the cuboid, and this was removed prior to allowing weight-bearing.(the only screw to confidently have been seen impinging on the calcaneo-cuboid joint).In one case, the fragment showed no signal on t1 or stir sequences, implying avascularity.Intravenous gadolinium-dtpa was therefore administered and the wall fragment failed to enhance, confirming non-viability.Localized rim enhancement indicated deep abscess formation in this patient which required removal of the implant.9 cases sagittal section of the talus showed increased signal on stir sequence.Increased stir signal was also seen in flexor accessories muscle in one patient.In one case, the posterolateral fragment remained unreduced (fig.4).Incidental osteoarthritis of the talonavicular joint was noted in one case, and of the navicular-cuneiform joint in one case.This report is for an unknown synthes using titanium alloy calcaneal plates and screws.This report captures a case where the fragment showed no signal on t1 or stir sequences, implying avascularity.Intravenous gadolinium-dtpa was therefore administered and the wall fragment failed to enhance, confirming non-viability.Localized rim enhancement indicated deep abscess formation in this patient which required removal of the implant.It also captures reported 9 cases of sagittal section of the talus which showed increased signal on stir sequence, increased stir signal was also seen in flexor accesorius muscle in one patient, in one case the posterolateral fragment remained unreduced, incidental osteoarthritis of the talo-navicular joint was noted in one case, and of the naviculo-cuneiform joint in one case.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11933404
• MDR Text Key: 267078149
• Report Number: 8030965-2021-04558
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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: 05/13/2021
• 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