MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.054S

Device Problems Device-Device Incompatibility (2919); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.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, 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the locking mechanism of the pfna blade was loose and defective after opening with the impactor.Another impactor was used to open another blade.No further information provided.Concomitant device reported: unk - impaction instruments (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) pfna-ii blade l95 tan.This is report 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.Visual inspection: upon visual inspection of the complaint device it can be seen that we have received the implant in a nearly closed and locked condition, the blade is able to spin in this condition.Furthermore, the received device shows dents and scratches, as well some color fading from use, but is otherwise in a good condtion.Functional test: during investigation a functional test was performed, the blade passed the functional test (b)(4).The article is working as intended.Document/specification review: drawings and revisions are in accordance to dhr of production lot 3l15722.All relevant features are defined on the used drawing revisions of dhr of production lot 3l15722.Furthermore, the reported device was assembled according to drawing, and all parts went through a 100% functional test, before they had left the production.Dimensional inspection: as the blade is fully functional, the complaint is unconfirmed and no further investigation will be done, as dimensional evaluation.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part number: 04.027.054s, lot number: 3l15722, manufacturing site: bettlach, release to warehouse date: 30.Jan.2019, expiry date: 01.Jan.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

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.H3, h6: 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.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 BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10316757
• MDR Text Key: 200306529
• Report Number: 8030965-2020-05222
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394230
• UDI-Public: (01)07611819394230
• 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,Followup
• Report Date: 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: 3L15722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: TRAUMA