MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PLATE-BENDING PRESS; INSTR,BENDING OR CONTOURING

Catalog Number 329.3

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Part: 329.300, lot: 1296785, manufacturing site: (b)(4), release to warehouse date: november 3, 2004.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 an unknown date, that it was discovered that the screw did not turn on the plate-bending press.There was no patient involvement.This report involves one (1) plate-bending press.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.H3, h6: investigation summary: investigation summary: based on the inspection by the local technician did "screw does not rotate".The complaint is therefore rated as confirmed.Product was not returned to the analysis site because the customer requested the device back, therefore no further investigation is possible.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: PLATE-BENDING PRESS
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9981512
• MDR Text Key: 191411947
• Report Number: 8030965-2020-02968
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 07611819021389
• UDI-Public: (01)07611819021389
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.3
• Device Lot Number: 1296785
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1