MAUDE Adverse Event Report: SYINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-PNTHES GMBH 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 310.507

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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.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, drill bit was found broken at tip after use.The broken part was left in patient.This report is for (1) 1.5mm drill bit w/depth mark mini qc/96 mm.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.Visual inspection: the drill bit ø1.5 w/marking l96/82 2flute (p/n: 310.507, lot number: f-20235) was received at us cq.Upon visual inspection, the tip of the drill bit is broken and the broken fragment is not returned.No other issues were identified with the returned device.No evidence of the broken part left in the patient was provided.Device failure/defect identified? yes.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the tip of the device is 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 history lot part # 310.507, lot # f-20235, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 08 dec 2016.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: 1.5MM DRILL BIT W/DEPTH MARK MINI QC/96 MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-PNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12110187
• MDR Text Key: 264086566
• Report Number: 8030965-2021-05509
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819156562
• UDI-Public: (01)07611819156562
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.507
• Device Lot Number: F-20235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention