MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.016S

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hto.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2020 during a tibial nailing procedure, the ria2 reamer head broke inside im canal.Fragments were generated and successfully removed without additional intervention.The procedure was successfully completed using the synream system.There was a surgical delay of approximately sixty (60) minutes.Concomitant device reported: unknown drive shaft (part # unknown, lot # unknown, quantity 1).This report is for one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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 history lot part #: 03.404.016s, synthes lot #: 37p6516, supplier lot #: 37p6516, release to warehouse date: 10-jan-2020, supplier: jabil ¿ monument.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history batch, null device history review device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation summary: 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.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation, as part remains in the patient and part was discarded by the facility.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.H11: corrected data: d9: complainant part is no longer expected to be returned for manufacturer review/investigation.

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.

Event Description

Concomitant device reported: drive shaft (part #: 03.404.035, lot #: h884350, quantity 1).

• Brand Name: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10655592
• MDR Text Key: 210673481
• Report Number: 8030965-2020-07820
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142382
• UDI-Public: (01)07612334142382
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 37P6516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT F/RIA 2 L520; DRIVE SHAFT F/RIA 2 L520; REAMER HEAD F/RIA 2 Ø10; UNK - DRIVE SHAFT; UNK - DRIVE SHAFT