MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REAMER 11 F/PFNA BLADE

Catalog Number 356.821

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.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 new zealand as follows: it was reported that on (b)(6) 2019, during pfna implantation, the reamer tip broke.This occurred during the process of reaming for insertion of the blade.No fragments were generated.Concomitant device reported: unknown pfna nail (part # unknown, lot # unknown, quantity unknown), unknown pfna helical blade (part # unknown, lot # unknown, quantity unknown) this report is for one (1) reamer 11 f/pfna blade.This is report 1 of 1 for (b)(4).

• Brand Name: REAMER 11 F/PFNA BLADE
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9617503
• MDR Text Key: 189642504
• Report Number: 8030965-2020-00548
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819291102
• UDI-Public: (01)07611819291102
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention