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

Catalog Number 04.027.036S

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states, but is similar to device marketed in the usa.Device was used for treatment, not diagnosis.A review of the device history record has been requested.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 by the loan kit technician that during a loan kit inspection, a fna blade 04.027.036 has seized onto fna extractor 03.010.411.This complaint involves two (2) devices.This report is for one (1) extraction screw for pfna blade.This report is 2 of 2 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 blade attached to the extraction screw.In addition, the received device shows dents and scratches, as well some color fading from use all over the surface of the part.Furthermore, one (1) of the four (4) lips are in a damaged and deformed condition (for details see picture attached "(b)(4) pictures from received parts.Pdf").Functional test: during investigation we were able to detach the blade from the extraction screw, and a functional test was performed, both parts passed the functional test (for details see picture attached "(b)(4) pictures from received parts.Pdf").Document/specification review: drawings and revisions are in accordance to dhr of production lot 9530254.All relevant features are defined on the used drawing revisions of dhr of production lot 9530254.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 material and dimension 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 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.The complaint is unconfirmed, as the complained issue could not be replicated and/or confirmed based on the available information.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 04.027.036s, lot: 9530254 , manufacturing site: bettlach, release to warehouse date: 23.Jun.2015, expiry date: 01.Jun.2025.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.

• Brand Name: PFNA BLADE PERF L105 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9771087
• MDR Text Key: 192026715
• Report Number: 8030965-2020-01549
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819369504
• UDI-Public: (01)07611819369504
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.036S
• Device Lot Number: 9530254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2020
• Date Manufacturer Received: 03/02/2020
• Patient Sequence Number: 1