MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.032

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

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

Event Date 11/27/2021

Event Type  malfunction  

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 for a surgery. During the surgery, the extraction piece does not screw into the nail, it remains loose for this reason it cannot be used for extraction. It was unknown if the surgery completed successfully. The patient outcome is unknown. Concomitant device reported: unk - nails: (part# unknown; lot# unknown; quantity: unknown). This complaint involves (1) device. This report is for (1) nail extractor. This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Reporter is a j&j representative. 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.

• Brand Name: NAIL EXTRACTOR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 13085390
• MDR Text Key: 283612729
• Report Number: 8030965-2021-10464
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.037.032
• Device Lot Number: 9286658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/24/2021 Patient Sequence Number: 1

Treatment

UNK - NAILS