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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 surgery for humeral diaphysis.The surgeon tried to drill the bone to insert a screw.When the surgeon was drilling with the drill bit attached to the radiolucent drive, a strong resistance was felt but the surgeon continued drilling.The drill bit began to idle rotation and stopped rotating.The surgeon used a guide wire instead and inserted a screw.The surgery was completed successfully with a 20 to 30 minute surgical delay.No further information is available.This report is for one (1) 3.2mm three-fluted radiolucent drill bit/needle point/145mm this is report 2 of 2 for (b)(4).This pc is related to (b)(4).This pc reports about synthes products (03.010.100) in the event.
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.H10 additional narrative: d10.E1.G2.H3, h6: part: 03.010.100.Synthes lot: u323603.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: november 13, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that drill bit ø3.2 calibr l145 3flute w/coup the threads of the drill bit are deformed, and no other issues were identified.The dimensional inspection was not performed due to the alleged complaint condition.The observed condition of drill bit ø3.2 calibr l145 3flute w/coup in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for drill bit ø3.2 calibr l145 3flute w/coup.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: the following drawing reflecting the current and manufacture revision was reviewed: -3.2mm three fluted drill radiolucent , 145 mm.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.D9.E3.

• 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
• MDR Report Key: 12212761
• Report Number: 8030965-2021-06004
• Device Sequence Number: 3839501
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 09/14/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP; DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - NAIL INSERTION HANDLES: RADIOLUCENT; UNK - NAIL INSERTION HANDLES: RADIOLUCENT; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA