MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM; REAMER

Catalog Number 357.403

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the tip of the drill bit was broken.It was unknown how and when it occurred.There was no information about procedure and patient.No additional information is available.This complaint involves one (1) device.This report involves one (1) 6.0mm/10.0mm stepped drill bit, cannulated/large qc/435mm.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, h6: a product investigation was conducted.Visual inspection: the reamer ø6/10 cann l435 no.511.760 (p/n: 357.403, lot number: u160215) was received at us cq.Upon visual inspection, it was noticed that a small portion of the device's cutting profile at the distal end was broken off.The broken piece was not received at us cq.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint was confirmed as a small portion of the device's cutting profile at the distal end was broken off.No definitive root cause could be determined based on the provided information.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.A device history record (dhr) review was conducted: manufacturing location: orchid unique / inspected, packaged and released by: monument release to warehouse date: 01-nov-2012, part number: 357.403, 6.0mm/10.0mm stepped drill bit cannulated/large qc/435mm, lot number: u160215 (non-sterile) , lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance received was reviewed and determined to be conforming.Packaging label log lppf, lmd/lpf rev e was reviewed and determined to be conforming.Note: only the sample size of thirteen parts needed to be repackaged after inspection.The remainder of the lot was packaged by the supplier.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11240403
• MDR Text Key: 243782752
• Report Number: 8030965-2021-00687
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819737709
• UDI-Public: (01)07611819737709
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.403
• Device Lot Number: U160215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1