MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM PEDICLE MARKER PIN, SPHERE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279729061
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, during a spinal fusion surgery when placing the pedicle marker at s1 on the right side, the shorter portion of the marker bent.There was no surgical delay.There were no patient consequences and the procedure was successfully completed.This report is for one (1) expedium spine system pedicle marker pin, sphere.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: a review of the receiving inspection (ri) for iexp pedicle marker set was conducted identifying that lot number mi99214 was released in a single batch.Batch1: released on february 08, 2021 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the exp ped marker pin-sphere was received at us customer quality (cq).The device was bent at the midsection of the device.No other defects were identified.The received condition was consistent with the complaint condition thus the complaint was confirmed.Dimensional inspection: measured dimensions: major diameter = conforming.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the complaint was confirmed for the received exp ped marker pin-sphere as the device was bent.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM PEDICLE MARKER PIN, SPHERE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11812923
• Report Number: 1526439-2021-00940
• Device Sequence Number: 3747975
• Product Code: LXH
• UDI-Device Identifier: 10705034199672
• UDI-Public: 10705034199672
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 279729061
• Device Catalogue Number: 279729061
• Device Lot Number: MI99214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP PED MARKER PIN-SPHERE