MAUDE Adverse Event Report: LDR MÉDICAL REMOVAL HOOK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AT9040R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2020-00228.
Event or Problem Description
It was reported that two removal hooks fractured during surgery.There were no reported patient impacts associated with this event.This is report one of two for this event.
Event or Problem Description
It was reported that two removal hooks fractured during surgery.There were no reported patient impacts associated with this event.This is report two of two for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: visual inspection revealed the tips have fractured.The complaint is confirmed.No medical records were available for review.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the instrument was being used or handled at the time of the damage.Device use: this devices are used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: REMOVAL HOOK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 11047842
• Report Number: 3004788213-2020-00257
• Device Sequence Number: 1024173
• Product Code: LXH
• UDI-Device Identifier: 03662663003049
• UDI-Public: (01)03662663003049(10)610078722/35
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: AT9040R
• Device Lot Number: 610078722/35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1