MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPEED DRILL KIT WITH 2.65MM DRILL BIT; STAPLE, FIXATION, BONE

Model Number	DK-265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.510k not available.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that there was implant fractures.This complaint involves one (1) device.This report is 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.H6: part number: dk-265, bme lot number: bdk170399, manufacturing date or release to warehouse date: 13july2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 20june2022.Dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of dk-265 was processed through a deviated process with no nonconformities noted.Deviation noted was for use of a streamlined labeling process as a test for process improvements.The identified process deviation is not relevant to the complaint condition as the deviation only affected the labeling process-flow and the complaint condition is not labeling related.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: SPEED DRILL KIT WITH 2.65MM DRILL BIT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9648994
• Report Number: 8030965-2020-00727
• Device Sequence Number: 401080
• Product Code: JDR
• UDI-Device Identifier: 00810633020302
• UDI-Public: (01)00810633020302
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Expiration Date: 06/20/2022
• Device Model Number: DK-265
• Device Catalogue Number: DK-265
• Device Lot Number: BDK170399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1