MAUDE Adverse Event Report: SYNTHES BRANDYWINE MAXILLARY DISTRACTOR BODY 20MM; BONE PLATE

Catalog Number 288.027

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device was not implanted/explanted.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.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

It was reported that during a maxillary distraction surgery, the surgeon applied distractors and when he was screwing it to the bone with the activation screwdriver the distractor bent.The surgeon then had to remove distractor and replace distractor body with a new one.Delay in surgery was twenty to thirty (20-30) minutes.The surgery was successfully completed.This is report 1 of 2 for com-(b)(4).

Manufacturer Narrative

A product investigation was completed: one maxillary distractor body, 20mm (part number 288.027, lot number 7185900) was received with the complaint that during a maxillary distraction surgery, the surgeon applied distractors and when he was screwing it to the bone with the activation screwdriver the distractor bent.The complaint condition is confirmed as the maxillary distractor was received in a bent condition and with the distal threaded portion cracked at the bend.Based on the returned condition and location of the bend it is most probable that the damage was a result of excessive force while using the alignment rods.However, as the application of force and method of use is unknown, the root cause cannot be definitively determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Per the technique guide, this device is part the maxillary distractor system.This system is specifically intended for the distraction of the maxilla utilizing a lefort i osteotomy.The desired foot plates are attached directly to the distractor body.The plates can then be advance through the use of the activation instrument directly with the distractor body.The returned maxillary distractor was received in a bent condition and with the distal threaded portion cracked at the bend.The device is bent approximately 8 degrees off axis with the peak of the bend at the proximal start of the threaded region.The proximal thread on the tension portion of the bend is cracked in the thread groove and extends approximately half of the circumference.The activation screw inside the barrel is also bent.Due to this bending the activation screw can no longer be fully rotated.The balance of the device is in working condition and shows minimal wear.Thus, the complaint condition is confirmed and consistent with the reported condition.A review of the current design drawing/manufactured revision for the top level and for the distraction barrel component was performed.The design history was found to not impact the complaint condition as it only concerned the part etchings.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Based on the returned condition and location of the bend it is most probable that the damage was a result of excessive force while using the alignment rods.Per the technique guide, the alignment rods should not be used as leverage for bending the footplates as this may cause damage to the distractor bodies.Bending force from the alignment rods would cause bending and fatigue at the proximal edge of the threaded portion which could subsequently resulted in the complaint condition during use.However, as the application of force and method of use is unknown, the root cause cannot be definitively determined.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

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review ¿ dhr of part #288.027, lot # 7185900 indicates that the reported product was manufactured on 05/06/2013 in accordance with all established requirements with no deviations or nonconformities reported.Dhr of part #288.027, lot # 7185900 further indicates that product lot underwent all specified inspection requirements and was found to meet all established criteria for release to warehouse with no nonconformities reports.The raw materials met all established requirements for use as intended with no nonconformities reported.There is no objective evidence within the dhr of the reported product indicating that the manufacturing of the lot or the raw material used is relevant to the complaint condition reported as malformed : bent/distorted/warped.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.

• Brand Name: MAXILLARY DISTRACTOR BODY 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: 5021725
• MDR Text Key: 23858655
• Report Number: 2530088-2015-10564
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK020505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 288.027
• Device Lot Number: 7185900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR