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

Catalog Number 310.221

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc, gfa, gff.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery on an unknown date.During the surgery, the drill bit was broken intra-articularly when it was inserted over the guidewire.The surgery was completed with unknown minutes delay.There were fragments generated and it was unknown if those are removed.There was no reported harm of the patient.Concomitant device reported: unknown guide wire (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 2.0mm cannulated drill bit/qc 150mm.This is report 1 of 1 for (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: part: 310.221, lot: f-12417, manufacturing site: selzach, supplier: sphinx werkzeuge ag, release to warehouse date: december 21, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the tip of the cannulated drill bit is broken off as complained.Approximately 3.5mm of the distal cutting tip section has broken off; three fragments were returned for investigation.Besides, the instrument presents normal signs of use.Dimensional inspection: drill bit checked with caliper per drawing.Outside diameter measured near the breakage: pass.Total length: failed due to breakage.Further dimensional inspection cannot be done due to the damage incurred.Document/specification review: drawing was reviewed during this investigation.The returned drill bit was manufactured in december 2011 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.With stainless steel the correct material was used, and the hardness value met the specifications.Summary: the complaint condition is confirmed as the tip of the drill bit is broken off.This production lot conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.A definitive root cause for the drill bit breaking could not be determined based on the provided information.However, we do suppose that the device encountered unintended forces, such as excessive force application during its use, which finally resulted in the breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10643132
• MDR Text Key: 210374453
• Report Number: 8030965-2020-07771
• 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
• Report Date: 09/15/2020

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-12417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Patient Outcome(s): Required Intervention