MAUDE Adverse Event Report: SYNTHES GMBH 3.2MM CANNULATED DRILL BIT; BIT, DRILL

Catalog Number	03.226.039
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: part #: 03.226.039, lot #: u225362, supplier: (b)(4), release to warehouse date: june 5, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the complaint device drill bit ø3.2/1.7 cann l225 4flut (product code: 03.226.039, lot number: u225362) was returned to customer quality (cq) west chester for investigation.The drill flute had the guide wire (product code: 02.226.000) inside it which is due to the blockage of the cannula by some foreign substance.Functional test: the guide wire along with the foreign substance were removed from the cannula of the drill flute during functional test.Can the complaint be replicated with the returned device(s)? the complaint cannot be replicated the two parts were separated during evaluation without any issue.Dimensional inspection: cannula diameter: measured dimension.Conforming.Measurement device used: caliper.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Drill bit ø3.2/1.75 cann 4flu.Complaint confirmed: the overall complaint is being confirmed as there was an unidentified substance blocking the cannula leading to issue.Conclusion: the drill bit was returned with the guide wire inside it.During investigation, the device were separated without any issues.The overall complaint is being confirmed as a foreign substance was seen blocking the cannula.A definitive assignable root cause could not be determined from the available information.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.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, during the surgery, the guide wire needles were used, and one of them became caught inside of the drill bit.The surgery was completed successfully without delay.There was no patient consequence.This report is for one (1) 3.2mm cannulated drill bit.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 3.2MM CANNULATED DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13060858
• Report Number: 8030965-2021-10398
• Device Sequence Number: 13829567
• Product Code: HTW
• UDI-Device Identifier: 07611819300286
• UDI-Public: (01)07611819300286
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Catalogue Number: 03.226.039
• Device Lot Number: U225362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø1.6 W/THREAD-TIP W/TROCAR L22
• Patient Sex: Unknown