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

Catalog Number	03.641.010
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12639102
• Report Number: 8030965-2021-08719
• Device Sequence Number: 1139886
• Product Code: HTD
• UDI-Device Identifier: 07611819353824
• UDI-Public: 07611819353824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.641.010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: SPINE; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAILS: TFNA; UNK - REAMERS