MAUDE Adverse Event Report: LDR MÉDICAL DISTR SCREWS Q-STRT 14MM 2PK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report.This device is manufactured by tsi (legal manufacturer).However, ldr-(b)(4) add a second label on the box (this second label is non compliant).From information provided, based on the product history records, the supplier investigation and the review of the case the root cause of this event is probably related to operator error during labelling process, if additional informations were received another report will be sent.

Event Description

Mobi-c p&f us : mislabeled mobi-c pins.From information provided by sales representative: two boxes of mobi-c were identified with mislabelling issue.The outside top of the box states 12 mm pins and the outside side of the box states 14mm pins.In addition the inside labelling indicate it contains 14mm pins.The pins actual length is 14 mm.This issue was found outside of surgery and no patient was involved.Investigation is in progress.

Event Description

It was reported that two boxes of mobi-c pins contained a labeling error.A label on the outside of the boxes stated "12mm" in the description.However, the other labels stated "14mm" and the physical product were "14mm".These were found outside of surgery and had no reported patient impact.

Manufacturer Narrative

Correction: a1, b5, b6, b7, e3, h1, h6 (patient code).Additional information: d4 (expiration date and udi), d10, e1 (middle name, address - line 2, state and telephone), g5 (pma/510k), h6 (method codes), h7 and h9.The pins were returned for evaluation.There is a labeling error on the outside of the packaging.It was found that these labels were incorrectly printed at the ldr austin facility.A field action was conducted via 3004788213-03272019-001r and reported to the fda.

• Brand Name: DISTR SCREWS Q-STRT 14MM 2PK
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8463269
• MDR Text Key: 140331116
• Report Number: 3004788213-2019-00103
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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 Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 0024-LDR
• Device Lot Number: 2017102450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3004788213-03272019-001R
• Patient Sequence Number: 1