MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/

Catalog Number 03.620.230

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

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) 2019, the x-ray-permeable part of the instrument broke intraoperatively while being impacted by the hammer.No surgery delay since another instrument was available.No adverse patient harm.Concomitant device reported: unknown impaction inst: hammer/mallet: trauma (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is for one (1) cann awl/probe w/radiolucent sleeve f/5.0/6.0/7.0mm screws.This is report 1 of 1 for (b)(4).

Event Description

Device report from synthes, reports an event in germany as follows: it was further reported that no fragments were generated.Backup device was available to use.Procedure was completed successfully.

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: the device has been received, the investigation is in progress, 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.

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.H3, h6: investigation summary investigation selection, investigation site: cq zuchwil, selected flow: damaged.Visual inspection: the returned device is broken is in a used condition.The black plastic part of sub-component 03.620.230.01 is broken.Has shown that the threaded tip section is completely broken off as complained.There are hammer bows visible at the top of the handle.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: feature: outer diameter plastic part result: pass.Feature: inner thread plastic part.Dimension measured: measurement not possible due to the damage incurred result: fail / measurement not possible due to the damage incurred document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.Based on the provided information we are not able to determine the exact cause of this complaint.By the evidence that this device was used successfully over its 7 (eight) years of lifespan, we do suppose that the device encountered unintended forces, such as excessive force application during its use, which finally resulted in the breakage.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H3, h4, h6: a review of the device history record.Device history lot, part: 03.620.230, lot: 8248066, manufacturing site: hägendorf, release to warehouse date: 11 jan 2013.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: PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/
• Type of Device: PROBE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9486226
• MDR Text Key: 194956670
• Report Number: 8030965-2019-71194
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 07611819973015
• UDI-Public: (01)07611819973015
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.620.230
• Device Lot Number: 8248066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/30/2019; 01/30/2020
• Supplement Dates FDA Received: 01/27/2020; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA