MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ADJUST WEDDING BAND 3.5-4.75; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188311301

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the primary surgery was performed with robert reid rrs system (p/n and lot number were unknown) on unknown date.On (b)(6) 2019, the extension surgery was performed with unknown reason.During the surgery, the reported device was tried to connect to already implanted robert reid rrs system (p/n and lot number were unknown) after hammering.However, it was difficult to connect even though the surgeon tried for about 30 min such as untightening the screw.Then, when the surgeon removed the reported connector, it was reported that the connector had disassembled.The surgery was completed by using alternative device, and eventually the connector could connect to robert reid rrs system.There was less than 30-min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (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.Visual examination found that the mountaineer adjust wedding band¿s components which include the rod holder and compression chip had fallen apart.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the mountaineer adjust wedding band falling apart cannot be positively determined.However, based on the observed failure it is suggested that higher than anticipated forces were placed on the adjust wedding band, thus resulting in its components falling apart.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).

• Brand Name: ADJUST WEDDING BAND 3.5-4.75
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8399881
• MDR Text Key: 141974696
• Report Number: 1526439-2019-51426
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034156767
• UDI-Public: (01)10705034156767
• Combination Product (y/n): N
• PMA/PMN Number: K042508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 188311301
• Device Catalogue Number: 188311301
• Device Lot Number: 5063216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1