MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø11 SM 130° L200 TAN; NAIL, FIXATION, BONE

Catalog Number 472.116S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2018

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.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.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a proximal femur nailing system surgery on (b)(6) 2018.During surgery, a proximal femoral nail antirotation (pfna-ii) nail broke.A new pfna-ii nail was used to complete the surgery.There was a surgical delay of 30 minutes.Patient's outcome is unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Facility address a device history record (dhr) review was conducted: part: 472.116s lot: l568508 manuf.Site: bettlach release to warehouse: 18.September 2017 expiry date: 01.September 2027 a manufacturing record evaluation was performed for the finished device lot l568508, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to specification.A product investigation was conducted.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 from the nail.Document/specification review: a dhr review was performed for the affected lot number l568508 (nail finish good product).No abnormalities, nor deviations neither ncs were detected which could lead to the complaint condition.Dimensional inspection: during this investigation, the outer diameter was measured and have fulfilled the specification according to the relevant drawing.However, the dimensional and position of the citrus shape where the nail was broken, was not measurable due to the breakage point.Besides, during the manufacturing process these features were inspected through the inspection sheet and the whole lot has passed its specifications.Therefore, the nail was manufactured according to its quality standards and any manufacturing issue has been excluded.Material or hardness review: for implants, there is no hardness test required/defined.However, the raw material certificate was reviewed 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 specification as well as in the manufacturing documentation no issue was identified.Due to any manufacturing issue has been excluded; 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 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 Ø11 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: 8356521
• MDR Text Key: 136856273
• Report Number: 8030965-2019-61202
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819837393
• UDI-Public: (01)07611819837393
• 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 Catalogue Number: 472.116S
• Device Lot Number: L568508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 02/26/2019
• Patient Sequence Number: 1