MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CROSSCONN R2R 35 TO 40MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1020-24-004S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the crossconn r2r 35 to 40mm had been returned in the disassembled condition.The components were fallen apart and one of the wave springs was observed to be missing.All the components returned were inspected and no damages were observed.No other issues were identified.The dimensional inspection was not performed due to the complex geometry of the device.The observed condition of the crossconn r2r 35 to 40mm was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the mating device in question was not returned for evaluation.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the components of the crossconn r2r 35 to 40mm were observed to have fallen apart.While no definitive root cause could be determined from the available information, it is probable that the crossconn r2r 35 to 40mm was fallen apart due to the exposure to excessive/unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.A manufacturing record evaluation was performed for the finished device.Product code: 102024004s, lot number: rl292469.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 22.05.2021, qty: (b)(4).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 japan reports an event as follows: it was reported that during a posterior cervical fusion (pcf) on (b)(6) 2022, when the surgeon tried to unscrew the attached setscrew of the 1st cross connector, the components of the applicator inner shaft happened to be dismantled.As it seemed difficult to reassemble the unit during the procedure, a replacement was prepared.Because the surgeon followed the same manner for unscrewing the attached screw of the 2nd cross connector, it became dismantled again.Another replacement was used.The procedure was completed with less than thirty minutes delay.Patient was stable.During manufacturer's investigation of the returned device it was identified that the components were fallen apart and one of the wave springs was observed to be missing.This report is for one (1) crossconn r2r 35 to 40mm.This is report 3 of 3 for (b)(4).

• Brand Name: CROSSCONN R2R 35 TO 40MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 14196470
• Report Number: 1526439-2022-00607
• Device Sequence Number: 4458862
• Product Code: KWP
• UDI-Device Identifier: 10705034520223
• UDI-Public: (01)10705034520223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192014
• 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: 1020-24-004S
• Device Catalogue Number: 102024004S
• Device Lot Number: RL292469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSCONN R2R 35 TO 40MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWDRIVERS
• Patient Sex: Unknown