MAUDE Adverse Event Report: SYNTHES BRANDYWINE REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR; MANDIBLE DISTRACTION DEVICES

Catalog Number 04.315.132

Device Problems Break (1069); Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(6) reported the following event: during a pediatric distraction procedure the tip of the flexible distraction arm (04.315.132) broke off during the activation of the instrument before use on the patient.The fragment was retrieved and discarded.The surgeon utilized another distraction construct for the patient to complete the procedure.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is unavailable.Date of event is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records indicates there were no relevant issues were found during manufacturing which could have caused or contributed to this complaint.All other records indicate the assembly was manufactured to specifications.Event occurred before the case; there was no patient involvement.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

During planning for the case, the flexible distractor extension arm got stuck on the distractor and when attempted to release the flexible extension arm, the tip broke.The broken tip was not retrieved.There was no patient contact or adverse event in relation to this complaint.This is report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.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.

Manufacturer Narrative

A product development investigation was performed for the subject device (part number 04.315.132, removable extension arm-flex 60mm for cmf distractor, lot number 69454591).The subject device was received with the small hexagonal wrench attachment area of the removable extension sheared leaving a portion of the standoff/neck.The remaining standoff/neck measured 1.19mm in diameter; within the low end of the drawing¿s tolerance.Overall, the removable extension appears to be in good, but used, condition omitting the sheared section of the removable extension.The size of the cloverleaf footplate (1.0mm) indicates this device was implanted in a child approximately 12 months in age or younger.This end of the removable extension has two mounting areas for hexagonal wrench attachments: the end of the outer housing/sleeve (p/n 04_315_125_9).Activation end (p/n 04_315_125_6).The inner sleeve assembly connects the activation end to the ab distractor (p/n 04_315_006).The outer sleeve contains the inner sleeve and allows the inner sleeve to engage and retain the ab distractor (p/n 04_315_006) via independent rotation of the inner sleeve.This inner/outer sleeve relationship is controlled by threads.These threads have a propensity to gall when they contain slight longitudinal centerline misalignments within the component welding of the inner sleeve assembly.Attempting to adjust a mounted inner sleeve under force with a misaligned inner sleeve assembly can produce a physical interference and ultimately galling between the two sleeves; causing the removable extension sleeves to cease independent rotation.These two sleeves move independently to control mounting the extension to a distractor assembly.Therefore, the resultant of this interference galling is the inability to remove the removable extension from the distractor which is exemplified within this complaint.The activation instrument (p/n 03.315.001) has instructions etched on it regarding general advance rates for the distractor.The craniomaxillofacial (cmf) distraction system technique guide states a recommended rate of activation as: < i year old (1.8mm/day); 2.5 turns per day.From the craniomaxillofacial (cmf) distraction system technique guide: ¿distraction of more than 1 mm per day is recommended to prevent premature consolidation in young children and neonates.¿ premature consolidation will provide a high resistance when operating the removable extension causing the type and location of shear found in this complaint.Within this complaint, there is no mention of a premature consolidation.There is mention of the assembled device being replaced without incident.Regarding this complaint, the shear pattern within the material is, in part, illustrated in a swirl type of pattern.This indicates the shear occurred during rotational operation.Also, the material sheared under a high and consistent force application evident by the amount of plastic deformation on the retained sheared surface.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR
• Type of Device: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4428600
• MDR Text Key: 5373003
• Report Number: 2530088-2015-10034
• Device Sequence Number: 1
• Product Code: MQN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.315.132
• Device Lot Number: 6945459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1