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

Catalog Number 04.027.054S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation (orif) surgery for femoral trochanteric fractures using proximal femoral nail antirotation (pfna) implants.After inserting the blade up to the desired position, the surgeon tried to connect the impactor to the blade, but the impactor came off before it was completely connected.The surgeon commented that he did not feel much response from the impactor as usual when he started to turn the impactor clockwise after the blade was inserted to the desired position.A second attempt yielded the same result.Three attempts were made in total, but the result was same.As a result, the surgeon used another size of blade for the surgery.The surgery was successfully completed with less than thirty (30) minutes delay.Patient was stable.This report is for a pfna blade.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: device history lot part: 04.027.054s, lot: 3l10081, manufacturing site: bettlach, release to warehouse date: 29.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.H3, h6: investigation summary: investigation selection investigation site: cq zuchwil, selected flow(s): device interaction/functional.Visual inspection: upon visual inspection of the complaint device it can be seen that we have received the implant in open/unlocked condition.Furthermore, the received device shows signs (scratches and color fading) from use, all over the part.Additionally one (1) of the four (4) lips is in a deformed condition.Functional test: during investigation a functional test was performed, the blade passed the functional test.Document/specification review: drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Furthermore, the reported device was assembled according to drawing, and all parts went through a 100% functional test, before they had left the production.Summary: as the blade is fully functional, the complaint is unconfirmed, therefore the in the investigation flow listed remaining investigation steps are not required.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 have to assume that during the operation an application error may have taken place.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 10621939
• MDR Text Key: 209654726
• Report Number: 8030965-2020-07677
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 3L10081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2020
• Date Manufacturer Received: 10/20/2020
• Patient Sequence Number: 1
• Treatment: IMPACTOR F/PFNA BLADE; IMPACTOR F/PFNA BLADE; PFNA-II BLADE L95 TAN; IMPACTOR F/PFNA BLADE