MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Catalog Number 03.503.476

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was conducted: manufacturing location: (b)(4), release to warehouse date: 20-nov-2017, release to warehouse date: 27-nov-2017: part number: 03.503.476 matrixmandible 1.5mm drill bit lot #: u287574, lot quantity: (b)(4), lot quantity: (b)(4): purchased finished goods travelers for both batches met all inspection acceptance criteria.Certificates of conformance supplied by (b)(4) dated 07-nov-2017 were reviewed and found to be conforming.Inspection sheets, material review, incoming final inspection 03if503476 rev j met all inspection acceptance criteria.Packaging label logs lppf, lmd/lpf rev ac were reviewed an found to be conforming.These lots met all dimensional, visual and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.A product investigation was conducted.Device condition: visual inspection performed at customer quality (cq) on the returned drill bit observed the drill bit as broken at its distal tip.The broken portion of device got lodged into the cannula along with the other half portion of the drill bit.No new issues were identified.The broken drill bit was not able to be disassembled from the cannula.The complaint condition was noted to be consistent with the given complaint condition and therefore the complaint was confirmed.Dimensional analysis and document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed and no design issues were identified.Dimensional inspection was not performed on the given device due to stuck condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Certificates of conformance, material review, incoming final inspection were reviewed and found to be conforming.These lots met all dimensional, visual, material and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.Conclusion: a definitive root cause for complaint condition could not be determined from the provided information.However, it is possible that any unintended excessive forces could have contributed to broken portions followed by stuck complaint condition.No product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the sagittal split ramus osteotomy (ssro) was performed on (b)(6) 2018 using the reported devices.It was reported that the drill tip could not come off the cannula when drilling.The surgery was completed successfully by using alternative device.There was no surgical delay and there was no adverse consequence to the patient.Patient outcome is reported as fine.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.(b)(4).

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7861217
• MDR Text Key: 119958128
• Report Number: 8030965-2018-56198
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 0761181997317
• UDI-Public: (01)0761181997317
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043310
• 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
• Report Date: 07/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476
• Device Lot Number: U287574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1