MAUDE Adverse Event Report: SYNTHES GMBH SURE-LOCK; FORCEPS

Catalog Number 03.641.010

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery with the tfna long nail.During the surgery, when the surgeon tried to insert the distal stop by using the surelock in question, the drill interfered with both holes of the nail, so the reaming ended up with 1.5 mm overreaming.After inserting the nail, the surgeon adjusted the front and back of the surelock by using the image.The surgery was completed successfully.No further information is available.Concomitant devices reported: unknown tfna - nail (part# unknown, lot# unknown, quantity 1).Unknown guides/sleeves/aiming: sleeve (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) sure-lock.This report is 1 of 1 of (b)(4).

• Brand Name: SURE-LOCK
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12639102
• MDR Text Key: 276635809
• Report Number: 8030965-2021-08719
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819353824
• UDI-Public: 07611819353824
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.641.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: SPINE; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAILS: TFNA; UNK - REAMERS