MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/PFNA BLADE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.010.411

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.It is unknown if device is available for return.Reporter is sales representative, no facility contact available, no facility phone number available device is not distributed in the united states, but is similar to device marketed in the usa.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.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 (b)(4) reports an event in (b)(6) as follows: it was reported, that during the insertion of a proximal femoral nail antirotation (pfna) on (b)(6) 2017, the tip of extraction screw for pfna blade broke off inside the blade intraoperatively.It is unknown if the fragments were recovered.Surgical delay and patient status are unknown.Concomitant parts reported: pfna blade (part# unknown, lot# unknown, qty 1); pfna nail (part# unknown, lot# unknown, qty 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant device is not expected to be returned for manufacturer.Review/investigation.Therapy date is (b)(6) 2017.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: EXTRACTSCR F/PFNA BLADE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7154845
• MDR Text Key: 96127926
• Report Number: 8030965-2017-51016
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819349483
• UDI-Public: (01)07611819349483(10)LOTNUMBERUNKNOWN
• 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
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1