MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONN O/C ANGLD 5.5-6.35X5.5TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179774555

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code : kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the universal connector cap thread was out when surgeon closed the cap and the cap driver shaft was worn away.The rod was broken when the surgeon used the in-situ bender.There was no fragment generated.The surgery was completed successfully with 20-minutes delay.There were no patient consequences are reported.This complaint involves six (6) devices.This report is for (1) conn o/c angld 5.5-6.35x5.5ti.This report is 2 of 6 (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.The complaint was confirmed for the received device.Although no definitive root cause can be determined it is possible the device experienced unintended forces.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 conn o/c angld 5.5-6.35x5.5ti was conducted identifying that lot number nw248925 was released in a single batch.Batch1: lot qty of units were released on (b)(6) 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.

• Brand Name: CONN O/C ANGLD 5.5-6.35X5.5TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11753767
• MDR Text Key: 266898407
• Report Number: 1526439-2021-00831
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034078120
• UDI-Public: 10705034078120
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 179774555
• Device Catalogue Number: 179774555
• Device Lot Number: NW248925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 06/04/2021
• Supplement Dates FDA Received: 06/02/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONN O/C ANGLD 5.5-6.35X5.5TI; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER; VIPER2 STRAIGHT ROD480 MM, COCR; X25 FINAL TIGHTENER