MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.055S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age, date of birth, and weight not available for reporting.Explanted date: device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.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 europe reports an event in (b)(6) as follows: it was reported that during a procedure to implant the proximal femoral nail anti-rotation (pfna) ii system on (b)(6) 2018, the pfna blade would not lock into the nail.The blade was not replaced and remains implanted in the patient in the unlock state.Surgery was completed successfully with a delay of approximately 5 minutes.Concomitant device reported: pfna nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) pfna ii blade.This is report 1 of 1 for (b)(4).

• Brand Name: PFNA-II BLADE L100 TAN
• 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: 7493807
• MDR Text Key: 107570303
• Report Number: 8030965-2018-53609
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394247
• UDI-Public: (01)07611819394247
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/15/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.055S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2018
• Initial Date FDA Received: 05/08/2018
• 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