MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L105 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.056S

Device Problems Device Operational Issue (2914); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Event date unknown, sometime this year.510k# unknown: device is not distributed in the united states, but is similar to device marketed in the usa.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).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 on an event in (b)(6) as follows: it was reported that dr.(b)(6)at (b)(6) hospital performed a pfna 2 surgery yesterday while locking unlocking the blade in the surgery, while doing so the blade became damaged.This is all information available.Complaint involves one part.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.Date of event reported as 2018, exact date is not known event description date returned to manufacturer dhr review was completed.Part number: 04.027.056s synthes lot number: l301535 release to warehouse date: 15.Feb.2017 expiry date: 01.Feb.2027 manufacturing site: bettlach no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned device.We have received the part for investigation.Upon visual inspection of the complaint device it can be seen that we have received back the part in a dismantled condition, and some parts were put together again wrong.Furthermore the article received has some fine traces of usage, but otherwise the article is in a good condition.Dhr review showed no issues.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.During investigation the part got assembled again and a functional test was performed, the blade passed the functional test.As the blade is fully functional, the pi is unconfirmed and no further investigation will be done, as material and dimension evaluation.Unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.No product fault could be detected.No corrective action 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.

Event Description

Device report from synthes europe reports an event in india as follows: it was reported during a procedure to implant the proximal femoral nail antirotation (pfna) on unknown date in 2018, while attempting to lock/unlock the pfna blade the blade was damaged.This report is for one (1) pfna ii blade this is report 1 of 1 for (b)(4).

• Brand Name: PFNA-II BLADE L105 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7422843
• MDR Text Key: 105290442
• Report Number: 8030965-2018-52999
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394254
• UDI-Public: (01)07611819394254(17)270201(L3015325
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.056S
• Device Lot Number: L301535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1