MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DRILL BIT/QC/85MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Model Number	310.15
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from colombia reports an event as follows: it was reported that during an unknown procedure on (b)(6) 2022, the drill bits in question were found to be dull by the specialist.There was no reported adverse patient impact.No further information was provided.This report is for a 1.5mm drill bit/qc/85mm.This is report 2 of 2 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.Additional procodes: gff, hwe, gfa.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the attachment.Visual analysis of the photo revealed that due to poor quality photo it is not possible to confirm evidence of the reported complaint device 1.5mm drill bit/qc/85mm.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 1.5mm drill bit/qc/85mm.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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.Lot # provided is not a valid lot number for this device, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo revealed that due to poor quality photo it is not possible to confirm evidence of the reported complaint device 1.5mm drill bit/qc/85mm.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 1.5mm drill bit/qc/85mm.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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
There was no surgical delay.The surgery was successfully completed.Patient status/ outcome: ok.

• Brand Name: 1.5MM DRILL BIT/QC/85MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15504268
• Report Number: 8030965-2022-07522
• Device Sequence Number: 5212107
• Product Code: HSZ
• UDI-Device Identifier: 10886982186027
• UDI-Public: (01)10886982186027
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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: Physician
• 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: 310.15
• Device Catalogue Number: 310.15
• Device Lot Number: F-21655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: K-WIRE Ø1 L150 SST
• Patient Sex: Unknown