MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø9 SM 130° L200 TAN; NAIL, FIXATION, BONE

Catalog Number 472.114S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Common device name: this report is for one (1) pfna-ii ø9 sm 130° l200 tan.Exp date is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during a proximal femur nailing system procedure, the proximal femoral nail antirotation (pfna) - ii nail broke.A new nail of the same size was used to complete the procedure.There was a 30-minute surgical delay.Patient outcome was unknown.Concomitant device reported: unknown pfna-ii helical blade (part #: unknown, lot #: unknown, quantity: 1) and unknown locking screw (part #: unknown, lot #: unknown, quantity: 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Visual inspection: the product was returned in a non-synthes bag.The laser marking was readable.Traces of use were visible, and the nail is broken at the citrus shape.Dimensional inspection: the outer (16.5 mm) and inner diameter (4.4 mm) were measured and have fulfilled the specifications.Material or hardness review: for implants, there is no hardness test required/defined.The raw material certificate was checked and the used raw material has fulfilled the specifications.Summary: based on the investigation result this complaint is rated as confirmed since the nail is broken as claimed by the customer.However, from the manufacturing point of view the relevant features were measured and have fulfilled its specifications as well as in the manufacturing documentation no issue was identified.Due to no manufacturing issue was identified and this complaint is not valid, therefore no additional actions are required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 472.114s lot: 8662265 manuf.Site: (b)(4) release to warehouse: 11.October 2013 expiry date: 01.October 2023 a manufacturing record evaluation was performed for the finished device lot 8662265, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to specification.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: PFNA-II Ø9 SM 130° L200 TAN
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8356466
• MDR Text Key: 137284709
• Report Number: 8030965-2019-61200
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819837379
• UDI-Public: (01)07611819837379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 472.114S
• Device Lot Number: 8662265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 02/21/2019
• Patient Sequence Number: 1