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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
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.
Event or Problem Description
It was reported that a fixation pin fractured during distraction of the disc space during surgery.Another fixation pin was used to complete the case.There was no reported impact on the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned fixation pin (pn ig008r) for the failure of fractured.Medical records were not provided for review.Device evaluation: visual inspection of the device reveals that it is fractured at the head.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces applied during use.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a fixation pin fractured during distraction of the disc space during surgery.Another fixation pin was used to complete the case.There was no reported impact on the patient.

• 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, n/a 10300 ; FR 10300
• MDR Report Key: 11797776
• Report Number: 3004788213-2021-00048
• Device Sequence Number: 4016871
• Product Code: LXH
• UDI-Device Identifier: 03662663002530
• UDI-Public: (01)03662663002530(10)19H30054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: N/A
• Device Catalogue Number: IG008R
• Device Lot Number: 19H30054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 70