MAUDE Adverse Event Report: SYNTHES GMBH 1.5 DB 6 STOP 13 90 SCRWDRVR MTRXMNDBL; DRILL, BONE, POWERED

Model Number	03.505.075
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthese reports an event in japan as follows: it was reported that this was a ssro for jaw deformity performed on (b)(6) 2023.Drilling was performed on the mandible; however, it could not be drilled.Although the drill bit was changed to different drill bits, the same result was obtained.The shaft was changed, and drilling was done successfully.Per the surgeon, the drill bits stopped during drilling.The surgery was completed successfully within 30 minutes delay.There was no harm to the patient.No further information is available.This complaint involves four (4) devices.This report is for one (1) drill bit ø1.5 w/stop l13/6 2flute this is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b.: additional pro-code: dzj d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E1: state: osaka e3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 1.5 db 6 stop 13 90 scrwdrvr mtrxmndbl had the cutting edges of the fluted tip blunt and worn.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection per guidance provided in windchill document , it was determined that the reusable instrument device was dull from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 1.5 db 6 stop 13 90 scrwdrvr mtrxmndbl would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: the following document was reviewed: windchill document ver a.2 part:03.505.075 lot:f-27348 manufacturing site: werk selzach supplier: (b)(4) release to warehouse date: 19 jun 2019 expiration date:na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 1.5 DB 6 STOP 13 90 SCRWDRVR MTRXMNDBL
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16845310
• Report Number: 8030965-2023-05441
• Device Sequence Number: 20719631
• Product Code: DZI
• UDI-Device Identifier: 10887587013619
• UDI-Public: (01)10887587013619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.505.075
• Device Catalogue Number: 03.505.075
• Device Lot Number: F-27348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø1.5 W/STOP L13/6 2FLUTE; DRILL BIT Ø1.5 W/STOP L13/6 2FLUTE; DRILL BIT Ø1.5 W/STOP L13/6 2FLUTE; HAND; HAND; SHAFT; SHAFT
• Patient Sex: Unknown