MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.033.001

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.A change to the surgical plan due a larger than usual lateral thigh incision was required.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent an unknown procedure for a diaphyseal fracture on (b)(6) 2019.During the procedure, femoral recon nail and two (2) distal screws were inserted.The nail was back slapped to compress the fracture.Upon proximal lock attempt through the recon locking holes, the drill/wire guides passed through the aiming arm did not align with the holes of the nail, as a result, the guide wires were passed anteriorly to the hole and on a number of attempts, completely anterior to the entire nail.The surgeon had to force the gold tissue protectors posteriorly by hand to find the alignment and proceed with drilling and screw insertion.  a larger than usual lateral thigh incision was required.Initially, it was believed that the problem was caused by the insertion handle/ aiming arm, but it was likely the connection between the insertion handle and the possible flex of the narrow proximal end of the nail that encourages misalignment when the nail is rotated in-situ via the aiming arm.The connection between the insertion handle and the nail remained very strong throughout the procedure - no loosening at all was noted. the instruments in question were still used to complete the procedure, but manual pressure over the wire guides to assist in a posterior direction was required, and the surgery was completed successfully after multiple attempts. there was a surgical delay of 30 minutes.There were no adverse effects expected.  concomitant devices: unknown outer protection sleeve/ wire guide/ trochar assembly (part# unknown, lot# unknown, quantity# 1); unknown distal screws (part# unknown, lot# unknown, quantity# 2).This complaint involves six (6) devices.This report is for one (1) radiolucent insertion handle frn.This report is 1 of 6 for (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FRN
• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8462526
• MDR Text Key: 140277185
• Report Number: 8030965-2019-62328
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07612334121776
• UDI-Public: (01)07612334121776
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.033.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• 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
• Patient Outcome(s): Required Intervention