MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DIA DRILL BIT W/8MM STOP 15MM LENGTH F/90° SCREWDRIVER; DRILL, BONE, POWERED

Catalog Number 03.505.044

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: additional product code: dzj.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.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 (b)(6) as follows: it was reported that this was an intraoral vertical ramus osteotomy surgery for a mandibular jaw deformity with the drill bit in question on (b)(6) 2022.In the surgery, the drill bit was broken, and the fragment was left in the body.The event took place in sequence as follows: after osteotomy of the mandible, a titanium plate (depuysynthes moj) was fixed using an instrument at a 90 ° angle.The drill bit was broken when the lower perforation to the bone was performed before screw insertion.The broken fragment was residual in mandible.It was confirmed by intraoperative x-ray.An attempt was made to remove it, but it was considered difficult to remove it because it was deep.Therefore, the plate was fixed at another place.The surgery was completed successfully with 40 minutes delay.No further information is available.Concomitant device reported: unk plates: cmf (part# unknown; lot# unknown; quantity: 1).Unk screws: locking: mandible (part# unknown; lot# unknown; quantity: unknown).Ukn insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1).This complaint involves one(1) device drill bit ø1.5 w/stop l13/6 2flute 90.° 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.H3, h4, h6: the device was 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.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.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.H3, h4, h6 investigation summary: 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 ø1.5 w/stop l15/8 2flute 90° was broken from the fluted tip, fragment was returned.Embedded device condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection for the drill bit ø1.5 w/stop l15/8 2flute 90° 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 ø1.5 w/stop l15/8 2flute 90° 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.Drawing/specifications reviewed: no issues.Dimensional inspection: n/a.Device history: part # 03.505.044.Lot # f-17635.Manufacturing site: (b)(4).Release to warehouse date: 07 may2015.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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.Corrected data: g1.

• Brand Name: 1.5MM DIA DRILL BIT W/8MM STOP 15MM LENGTH F/90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14044981
• MDR Text Key: 293171475
• Report Number: 8030965-2022-02282
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819187603
• UDI-Public: (01)07611819187603
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.044
• Device Lot Number: F-17635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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 - INSERTION INSTRUMENTS: TRAUMA.; UNK - PLATES: CMF.; UNK - SCREWS: LOCKING: MANDIBLE.
• Patient Outcome(s): Required Intervention