MAUDE Adverse Event Report: SYNTHES BALSTHAL 1.3MM CURVILINEAR DISTRACTOR R40/RIGHT; MANDIBLE DISTRACTION DEVICES

Model Number	04.500.240
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available for reporting.Concomitant device therapy date is unknown.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site: (b)(4) manufacturing date: 19.July 2013.Customer quality (cq) engineering investigation: this complaint was unable to be confirmed at cq.Implants were received at cq assembled (with no x-rays for evidence of over distraction provided), therefore the reported condition of over distraction was not able to be confirmed based on the as received condition of the devices at cq.The complaint condition was not able to be replicated at customer quality (cq).No new malfunctions were identified as a result of the investigation.The returned devices are implants in the curvilinear distraction system indicated for internal distraction that advance the mandible along a curved path.The system is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.Instructions for use are available in technique guide.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed at cq for the returned devices as part of this investigation.No product design issues or discrepancies were observed.04.500.240: visual /dimensional inspection: implant is discolored with bioburden/dried blood.Implant was received at cq assembled.The reported condition of over distraction was not able to be confirmed based on the as received condition of the device at cq.The rack has either been cut to length or broken.Drawing specification for overall device length is 52.22mm +/- 0.8mm per left curvilinear distractor assembly drawing.The returned device length measures 31.09mm.The rack ends just distal to the "15" etching.Also the cut end of the rack is wider than the remainder of the rack due to post manufacturing damage.The width of the area at the cut/broke edge measures 3.70mm which is larger than specification of 3.02mm +/-0.3mm.The distractor tab does not appear to be deformed, as it is still either partially or entirely engaged.Dhr review: no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Drawing review: no product design issues or discrepancies were observed.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 or Problem Description
It was reported patient was implanted with a 1.3mm curvilinear distractor on (b)(6) 2017.Surgeon states it was necessary to over-advance the distractor in order to obtain full distraction distance.Device was utilized to complete the treatment plan and was removed as planned on (b)(6) 2017.Surgeon stated the distractor tab that prevents reversing appears to be deflected out of the way preventing it from engaging.Concomitant devices reported: activation instrument for curvilinear distractor (part 03.500.016, lot number unknown, quantity 1).This report is for one (1) 1.3mm curvilinear distractor/right.This is report 2 of 2 for (b)(4).

• Brand Name: 1.3MM CURVILINEAR DISTRACTOR R40/RIGHT
• Common Device Name: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• MDR Report Key: 6767405
• Report Number: 3009450863-2017-10023
• Device Sequence Number: 16496881
• Product Code: MQN
• UDI-Device Identifier: 10887587016863
• UDI-Public: (01)10887587016863(10)8541880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.500.240
• Device Catalogue Number: 04.500.240
• Device Lot Number: 8541880.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACTIVATION INSTR. (03.500.016, LOT UNK, QTY 1)
• Patient Age: 6 MO