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 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2021 the tip of the drill bit is fractured and part of it remains in the bone.Procedure was completed successfully.This report is for one (1) 2.0mm cannulated drill bit/qc 150mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procodes: gfa, hwe, gff d7 h6: part: 310.221.Lot: f-24434.Manufacturing site: selzach.Supplier: synthes gmbh.Release to warehouse date: june 19, 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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: d9 h3, h6: part: 310.221.Lot: f-24434.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: june 19, 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the drill bit ø1.1 l75/61 2flute (p/n:310.221, lot number: f-24434) was received at us customer quality (cq).Upon visual inspection, the distal end of the drill bit was observed to be broken.The broken fragment was not returned.No other issues were identified with the returned device.The reported condition of embedded device could not be confirmed as no x-rays were provided.Device failure/defect identified? yes.Document/specification review: current and manufactured revisions 2.0 cannulated drill with quick coupling, dimensional inspection: shaft diameter just below the flutes of the drill bit: result: conforming complaint confirmed? yes.Investigation conclusion: this complaint could be confirmed as the tip of the drill bit was identified to be broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• 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
• MDR Report Key: 12310456
• MDR Text Key: 266171081
• Report Number: 8030965-2021-06584
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819086074
• UDI-Public: (01)07611819086074
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F-24434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 10/07/2021
• Supplement Dates FDA Received: 10/05/2021; 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention