MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE 2.4MM DRILL BIT J-LATCH/90MM FOR 03.503.046; DRILL, BONE, POWERED

Catalog Number	03.503.471
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Device report from (b)(6) reports an event as follows: it was reported that this patient underwent surgery on (b)(6) 2020 to replace a mandibular plate, treating mandibular osteomyelitis.The surgeon tried to attach the drill bit to the drill.But the drill bit did not go through the drill¿s inlet.The procedure was completed with less than thirty (30) minutes delay.Patient was stable.This report is for a matrixmandible 2.4mm drill bit j-latch.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part:03.503.471, synthes lot: u272984, supplier lot: n/a, release to warehouse date: january 05, 2018, expiration date: n/a, supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The product was returned to zuchwil customer quality for evaluation.Customer quality then conducted visual inspection and dimensional check of the returned device.During the visual inspection, the breakage of the device could be confirmed.Furthermore, the cutting edges were found blunt which are consistent with often and intensive use.No other visual damage could be observed.The returned device was tested for dimensional inspection with the result that the for the complaint relevant dimensions were found to be within specifications.It should be noted that product failure is multifactorial.Based on the condition of the device, we can assume that this product was an often and intensive used instrument.We suppose that the bad condition of the device before surgery, in combination with a mechanical overload situation during use, could lead to the breakage.Because of that, we would like to draw your attention to the leaflet ¿important information¿: check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: MATRIXMANDIBLE 2.4MM DRILL BIT J-LATCH/90MM FOR 03.503.046
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11167002
• Report Number: 8030965-2021-00289
• Device Sequence Number: 17025765
• Product Code: DZI
• UDI-Device Identifier: 07611819975262
• UDI-Public: (01)07611819975262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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 Catalogue Number: 03.503.471
• Device Lot Number: U272984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/19/2021
• 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: UNKNOWN DRILL