MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD CUTTER 3.5 AND 4.0 RODS; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number 2020-00-135

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Event date is unknown.Reporter is a j&j sales representative.Investigation flow: visual.Visual inspection: the rod cutter 3.5 and 4.0 rods (part #: 202000135 / lot #: gs676414) was received at us cq.Upon visual inspection, foreign substance was identified on the device on the cutting edge which could be blood stains and can be removed on cleaning.No other issues were identified with the device.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Dimensional inspection: dimensional inspection was not performed due to a definitive finding of rust on the device.Conclusion: the complaint was not confirmed for the received crod cutter 3.5 and 4.0 rods (part #: 202000135 / lot #: gs676414) as no discoloration or fading was observed.However, foreign substance (could be blood stains) was identified was found on the device.Although no definitive root-cause can be determined its possible that maintenance of the device could have contributed to this condition.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot a review of the receiving inspection (ri) for rod cutter 3.5 and 4.0 rods was conducted identifying that lot number gs676414 was released in two batches: batch 1: lot qty of (b)(4) units were released on apr 17, 2020 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on oct 12, 2020 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.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the instrument was discolored after sterilization.There was no surgery and patient impacts are reported.This complaint involves one (1) device.This report is for (1) rod cutter 3.5 and 4.0 rods.This report is 1 of 1 for (b)(4).

• Brand Name: ROD CUTTER 3.5 AND 4.0 RODS
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11907327
• MDR Text Key: 265430457
• Report Number: 1526439-2021-01062
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034530536
• UDI-Public: 10705034530536
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2020-00-135
• Device Catalogue Number: 202000135
• Device Lot Number: GS676414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2021
• Date Device Manufactured: 04/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1