MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 patient underwent an open reduction internal fixation (orif) surgery for femoral trochanteric fractures using the pfna implants.During the surgery, the surgeon had a difficulty in connecting the impactor to the blade.She could not turn the handle of impactor because the locking applied to the blade was strong.At that time, as the key was attached to the blade, it was easier to apply force, and also the surgeon was aware that the impactor should be connected to the blade in a straight line.Both a nurse and the surgeon tried to turn the handle of impactor, but they could not because it was too tight.A nurse turned the handle of impactor strongly, then it could connect the impactor to the blade.The blade insertion and locking were done without any problem.The surgery was successfully completed with a less-than-30-minute delay.This is report 2 of 2 for (b)(4).

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10536257
• MDR Text Key: 207032644
• Report Number: 8030965-2020-06986
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394216
• UDI-Public: (01)07611819394216
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.052S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IMPACTOR F/PFNA BLADE