MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.221

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant medical products: date of concomitant therapy is (b)(6) 2022.Reporter is a j&j employee.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 Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent orif for radial head with the product in question.The surgeon used two screws to fix the radial head fracture.The surgeon notices the breakage of the drill bit during the second drilling after the first insertion.The cause was the interference with the temporarily fixed k-wire during the first drilling, and the surgeon recognized the same.Since there were two drill bits, the second insertion was made using the other bit.The image showed shadow that appeared to be debris, but it was left in the body.No further information is available.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity: 2) unk - guide/compression/k-wires (part# unknown; lot# unknown; quantity: unknown) unk - drill bits: trauma (part# unknown; lot# unknown; quantity: 1) this complaint involves one (1) device.This report is for one (1) drill bit ø2/1.15 cann l150/48 3flute f/ this is report 1 of 1 for complaint (b)(4).

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.D2: additional procodes: gff, hwe, gfa.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.

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.Photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the tip of drill bit ø2/1.15 cann l150/48 3flute f/ was broken.The photo does not show the enbeded device so the condition cannot be confirmed.The hcs 2.4/3.0 was reviewed surgical technique and the following relevant statements were found.: warning: avoid forcefully advancing or bending the drill bit as this may cause the drill bit to break.Do not advance the drill bit beyond the wire.When drilling is complete, slowly pull the drill bit straight out while running the power tool in ¿forward mode¿ to ensure the guide wire stays in place.The overall complaint was confirmed for drill bit ø2/1.15 cann l150/48 3flute f/ there is no indication that a design or manufacturing issue has caused the complaint condition.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 evaluation: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the drill bit ø2/1.15 cann l150/48 3flute f/ was found the tip broken.There is not enough evidence to confirmed the complaint of embedded.Broken fragment was not returned.No other defect was found.A dimensional inspection for the drill bit ø2/1.15 cann l150/48 3flute f/ was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 condition of the drill bit ø2/1.15 cann l150/48 3flute f/ would contribute to the complained device issue.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 history lot part # 310.221, synthes lot # pe05157, supplier lot # pe05157, release to warehouse date: may 27, 2022, supplier: (b)(4).No ncrs were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: 2.0MM CANNULATED DRILL BIT/QC 150MM
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16212162
• MDR Text Key: 307766147
• Report Number: 8030965-2023-00665
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819086074
• UDI-Public: (01)07611819086074
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.221
• Device Lot Number: PE05157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: TRAUMA; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention