MAUDE Adverse Event Report: SYNTHES BRANDYWINE FLEX CABLE EXTENSION 40MM F/TI MIDFACE DISTRACTOR; PLATE, BONE

Catalog Number 487.994

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).The body of the subject device is still implanted in the patient.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.This lot was released to the synthes (b)(4) warehouse for distribution with the same lot number on jan 26, 2016.The extension arm component of the subject device has been received and is currently in the evaluation process.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 (b)(4) reported an event in (b)(6) as follows: it was reported that the flexible extension arm component of the midface extractor broke postoperatively.The flexible extension arm is located outside of the patient's soft tissue and is attached to the activation end of the distraction device body which is affixed to the patient's bone.According to the patient's father, before the incident, the activation through the extension arm was very stiff.On the day of the incident, (b)(6) 2016, the patient woke up without any defect on the distractor; it was broken during the activation.It is unknown why the extension arm broke.The broken extension arm was subsequently removed and the patient will continue the distraction process without the extension flexible arm, directly through the activation end of the distraction body.The distractor body will be explanted in approximately three to four months (from the date of this report).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Clarification: the product was shipped to and released by (b)(4) on january 26, 2016.However, the device was manufactured by (b)(4) on january 18, 2016.As such, that information was populated in the applicable medwatch fields.Manufacturing investigation evaluation: the applicable drawings were reviewed to determine product features that may be relevant to the complaint condition reported as ¿broken: postoperatively.¿ the following features of the reported product are identified as pertinent: outer diameter and torque to failure were identified.The raw material was verified for the components.All features identified above were verified on the returned product for conformance against established requirements.These features were conforming to specifications.The torque to failure feature cannot be measured as this is obtained at the raw material state.The returned material was verified and identified and conforming.In addition, all features identified were verified for conformity and acceptance.The complaint condition is confirmed; however, from a manufacturing perspective, the complaint is unconfirmed due to measurements of features all being conforming and meeting specifications.Product investigation summary: visually, some scratches are present on the surface and the bent flexible cable was detected, which indicates post-manufacturing damages.No manufacturing related failure was found.It is recommended that the user always works according the surgical guide and that worn or damaged instruments be replaced prior to surgery.The return device was likely worn from normal use and servicing.No manufacturing related failure could be found.Root cause was not determined, but no indication for product related issue was found.Device 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: FLEX CABLE EXTENSION 40MM F/TI MIDFACE DISTRACTOR
• Type of Device: PLATE, BONE
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5668909
• MDR Text Key: 45570767
• Report Number: 2530088-2016-10134
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK022005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 487.994
• Device Lot Number: 7992058
• Other Device ID Number: (01)07611819809543(10)7992058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 15