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Device Problem Failure to Align (2522)
Patient Problem No Code Available (3191)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown tfna nail/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. 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. 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 medical products: 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) unk - nails: femoral. This report is 4 of 6 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
MDR Report Key8462534
MDR Text Key140276577
Report Number8030965-2019-62332
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/28/2019 Patient Sequence Number: 1