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

Catalog Number	IG008R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
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 an arthrodesis c3-c4, one of the retractor pins broke cleanly and a piece remained in the patient's vertebra.There is an increased risk of infection because part of the material (screw thread 1cm) remained in the patient.The procedure was interrupted (there was a surgical delay).
Additional Manufacturer Narrative
Corrections in a2, b5, d4: udi number, and h5.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: product was not returned and photos were not provided.Device evaluation unable to be completed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis 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 zimvie¿s control.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that during an arthrodesis c3-c4, one of the retractor pins broke cleanly and a piece remained in the patient's vertebra.There is an increased risk of infection because part of the material (screw thread 1cm) remained in the patient.The procedure was interrupted (there was a surgical delay).Post-operatively, the device fragment caused significant artifacts making an mri of the cervical spine uninterpretable.

• Brand Name: RETRACTOR FIXATION PIN
• 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16439093
• Report Number: 3004788213-2023-00018
• Device Sequence Number: 3126556
• Product Code: LXH
• UDI-Device Identifier: 03662663002530
• UDI-Public: (01)03662663002530(10)R14G170-S096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IG008R
• Device Lot Number: R14G170-S096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Unknown