MAUDE Adverse Event Report: LDR MEDICAL RETRACTOR FIXATION PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IG008R
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during impaction, two caspar pins bent and ended up breaking at the tip.The tips were retrieved and other pins in the box were used to complete the case.There was no patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number & serial number, d9, g1, and h3.Additional information in d4: udi number, and h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3004788213-2024-00042.
Event or Problem Description
It was reported that during impaction, two caspar pins bent and ended up breaking at the tip.The tips were retrieved and other pins in the box were used to complete the case.There was no patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive forces applied during use.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that during impaction, two caspar pins bent and ended up breaking at the tip.The tips were retrieved and other pins in the box were used to complete the case.There was no patient impact.This is report two of two for this event.

• Brand Name: RETRACTOR FIXATION PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 19430585
• Report Number: 3004788213-2024-00043
• Device Sequence Number: 8336323
• Product Code: LXH
• UDI-Device Identifier: 03662663002530
• UDI-Public: (01)03662663002530(10)14D484-S061
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

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: IG008R
• Device Lot Number: 14D484-S061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 09/17/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic