MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.033S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Device has not been explanted yet.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during the removal the back of the proximal femoral nail anti-rotation (pfna) blade came off making extraction impossible.The blade did not look broken on the x-ray so a standard removal set was sent.This was inadequate given the blade was broken.The patient was closed up and will come back to revise when the wound is healed in six to eight (6-8) weeks.The blade and nail were going to be removed as they were both sitting proud and causing irritation.Concomitant parts reported: pfna nail (part/lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: PFNA BLADE PERF L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• 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: 7131023
• MDR Text Key: 95320147
• Report Number: 8030965-2017-50853
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819368972
• UDI-Public: (01)07611819368972(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.033S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention