MAUDE Adverse Event Report: SYNTHES GMBH 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number	03.010.100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for trochanteric fracture of femur.During the surgery, it was very hard to insert an end cap with the screwdriver.The surgery was completed within 30 minutes delay.No further information is available.Concomitant devices reported: unknown end cap (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 3.2mm three-fluted radiolucent drill bit/needle point/145mm.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.H3, h6: a product investigation was conducted.Visual analysis of the returned sample revealed that tip of drill bit ø3.2 calibr l145 3flute w/coup4 was little dull/blunt, and no other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.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 dull condition of the drill bit ø3.2 calibr l145 3flute w/coup was consistent with complaint condition.While no definitive root cause could be determined, it is probable that the drill bit ø3.2 calibr l145 3flute w/coup got dull due to being in usage for awhile.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.100.Lot: u323603.Manufacturing site: selzach.Supplier: orchid bridgeport.Release to warehouse date: 13.Nov.2018.A manufacturing record evaluation was performed for the finished device lot number, 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.
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.H3, h6: the subject device has been 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.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of proximal end of humerus.Bone quality of the patient was age-appropriate but could not be drilled with the drill bits in question.The surgeon pointed out that the power of colibri ii itself seemed to be also extremely insufficient, but most of all, the reason why the drill bits could not drill bones was probably because they had very poor sharpness since they were the type of product used multiple times.Another manual drill was used in the surgery, and the surgery was completed successfully within thirty (30) minutes surgical delay.Patient outcome is reported as stable.No further information is available.This report is for (1) 3.2mm three-fluted radiolucent drill bit/needle point/145mm this is report 2 of 2 for complaint (b)(4).

• Brand Name: 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12925634
• Report Number: 8030965-2021-09951
• Device Sequence Number: 14691877
• Product Code: HTW
• UDI-Device Identifier: 07611819775374
• UDI-Public: (01)07611819775374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2021

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: 03.010.100
• Device Lot Number: U323603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 01/21/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/18/2022; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2018
• 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 Ø3.2 CALIBR L145 3FLUTE W/COUP.
• Patient Age: 78 YR
• Patient Sex: Female