MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BENDING TEMPLATE FOR LOCKING CALCANEAL PLATE-SHORT

Catalog Number	329.607
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, the distributor received the bending template to deliver to the hospital for a surgery planned on (b)(6).However, the distributor found out that the bending template was broken when it was received in a loan set.Another device was arranged before delivery.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: BENDING TEMPLATE FOR LOCKING CALCANEAL PLATE-SHORT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8376063
• Report Number: 8030965-2019-61529
• Device Sequence Number: 1606301
• Product Code: HWT
• UDI-Device Identifier: 07611819723054
• UDI-Public: (01)07611819723054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 329.607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/27/2019
• Patient Sequence Number: 1