MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT FOOT/20MM; BONE PLATE

Catalog Number 487.963

Device Problems Failure To Adhere Or Bond (1031); Unintended Movement (3026)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

It was reported that this complaint is for the first surgery dated (b)(6) 2015 the distractors placement was very complicated and after many hours of trying to place it, the distractors were derailed from the backplate.Surgical delay: many hours (exact time unknown).This report is 2 of 6 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information reported.The investigation could not be completed; no conclusion could be drawn, as no product was received.The manufacturing location for part # 487.963 / lot # 6879052 is (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update (based on operating room notes received on (b)(6) 2015): it was reported that the surgeon(s) placed vertical distractors in the bilateral mandibular ramus and performed an upper-level osteotomy on the mandibular tongue (per described technique).At the 24-hour follow-up, a panoramic radiograph confirmed left-side displacement and early signs of right-side displacement.Two revision procedures were performed thereafter (and addressed in com-(b)(4) and com-(b)(4)).

Manufacturer Narrative

The first revision procedure occurred on (b)(6) 2015.At this time, the devices were repositioned, but not removed.The actual explant was scheduled for (b)(6) 2015, but may not have occurred until (b)(6) 2015.Therefore, the exact date of explant is unknown.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.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that the: the out of tolerance parallelism condition of the flat of the slip fastener component p/n 487.962.2 with the flat of the locking distal foot component p/n 487.963.1, along with the lack of radii at the upper r5 corners and oversized r6 corner radii of the slip fastener component may have created potential for the complaint condition reported as does not/will not function, will not hold.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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the first surgery, the surgeon inserted vertical distractors in bilateral mandibular branch.The surgery lasted two (2) hours.This is report 2 of 14 for (b)(4).

Manufacturer Narrative

Additional manufacturing dates for this device include: july 27, 2012, july 13, 2013, december 9, 2013, march 5, 2014, and november 4, 2014.Device history review: device history records (dhr) for the reported product lot indicates that the lot was produced on july 10, 2012.Dhr for the reported fully assembled product lot and sub-components show that ((b)(4)) non-conformance report (ncr) was initiated in response to minor documentation non-conformities detected during final inspection of the product lot.The ncr indicates that the detected documentation non-conformities were corrected and the lot dispositioned as ¿conforms¿ since inspection records for the lot indicate that the product met all established dimensional, functional, and visual requirements for release.A review of the dhr for the reported lot found no objective evidence indicating that the manufacturing of the reported lot or the reported documentation nonconformities contributed to the complaint condition reported as does not/will not function : will not hold.The dhr for the reported product lot also indicates that the lot was repackaged and relabeled on july 27, 2012 ((b)(4) pieces), july 13, 2013 ((b)(4) pieces), december 9, 2013 ((b)(4) piece), march 5, 2014 ((b)(4) piece), and november 4, 2014 ((b)(4) pieces).However, there is no objective evidence that the reported repackaging and re-labeling contributed to the complaint condition reported as does not/will not function : will not hold.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.

Event Description

This report is 2 of 7 for (b)(4).

Manufacturer Narrative

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: TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT FOOT/20MM
• Type of Device: BONE PLATE
• 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: 4674574
• MDR Text Key: 5624911
• Report Number: 2530088-2015-10110
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 487.963
• Device Lot Number: 6879052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR