MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM ROD BENDER, IN-SITU

Model Number	286240040
Medical Device Problem Codes	Device Slipped (1584); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: part number: 286240040, lot number: 1207mi.Supplier: (b)(4).Batch1: released on (b)(6) 2008 with no ncr generated during production.The product was returned to us customer quality(cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that connecting ends of the in-situ rod bender were found to be worn and deformed.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection, it is determined that the reusable instrument device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed stripped condition of in-situ rod bender would have contributed to the complained device interaction issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2021, the instruments are worn and slipped off the rod.The surgeon used different bending tools to complete the procedure.There were no patient consequences.This report involves one (1) expedium spine system rod bender, in-situ.This is report 1 of 2 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM ROD BENDER, IN-SITU
• Common Device Name: BENDER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13654580
• Report Number: 1526439-2022-00303
• Device Sequence Number: 11383096
• Product Code: HXW
• UDI-Device Identifier: 10705034341859
• UDI-Public: (01)10705034341859
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 286240040
• Device Catalogue Number: 286240040
• Device Lot Number: 1207MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2008
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IN-SITU ROD BENDER.; UNKNOWN RODS.
• Patient Sex: Unknown