MAUDE Adverse Event Report: SYNTHES GMBH 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number	03.010.101
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an orif for distal femoral diaphyseal fracture.During drilling, something that looked like a black piece of plastic came out.The surgeon took it off once to check.There was a plastic piece on the connection part, and the connection part of drill was black.The connection part was flushed with saline, and another drill was attached.Then, a screw was inserted.The plastic pieces that fell into the body were removed with gauze.The surgery was completed successfully without any surgical delay.Patient was stable.This report is for a 4.2mm three-fluted radiolucent drill bit/needle point/145mm.
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 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 j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the radiolucent plastic drills drill bit ø4.2 calibr l145 3flute w/coup had a sticky, black foreign substance covering the entire radius of the surface.No other issues were found.Therefore, the reported condition can be confirmed.According to the ifu gp0680-f: it is recommended that devices should be reprocessed as soon as is reasonably practical following use.Disassemble device, if device is able to be disassembled, prior to cleaning.Refer to technique guide or other supplemental information for specific device disassembly and/or reassembly instructions.Open devices with ratchets, box locks or hinges.Remove sharp devices for manual cleaning or place into a separate tray.Lumens/cannula of devices should be manually processed prior to cleaning.Lumens/cannula should first be cleared of debris.Lumens/cannula should be brushed thoroughly using appropriately sized soft-bristled brushes and twisting action.Brushes should be tight-fitting.Brush size should be approximately the same diameter of the lumen/cannulation to be cleaned.Using a brush that is too big or too small for the diameter of the lumen/cannulation may not effectively clean the surface of a lumen/cannulation.After brushing lumens/cannula, blow clean compressed air through lumen/cannulation to clear debris, if necessary soak and/or rinse heavily soiled devices or cannulated devices prior to cleaning to loosen any dried soil or debris.Use a neutral ph enzymatic soak or detergent to soak devices.Follow the enzymatic cleaner or detergent manufacturer¿s instructions for use for correct exposure time, temperature, water quality and concentration.Use cold tap water to rinse devices.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the drill bit ø4.2 calibr l145 3flute w/coup would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part:03.010.101; lot:u434269; manufacturing site: werk selzach; supplier: (b)(4).Release to warehouse date: 12 july 2023.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.2MM 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20240382
• Report Number: 8030965-2024-11672
• Device Sequence Number: 8913114
• Product Code: HTW
• UDI-Device Identifier: 07611819775381
• UDI-Public: (01)07611819775381(10)U434269
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 03.010.101
• Device Lot Number: U434269
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 10/15/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/09/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: RADIOLUCENT-DRIVE
• Patient Sex: Unknown