MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179702000S

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in the united kingdom as follows: it was reported that on (b)(6) 2022, the surgeon reported that the instrument was spinning in set screw head and was unable to reach torque limit.This happened to multiple instruments, until a suitable alternative instrument was used and the procedure completed safely.One of the set screws stripped whilst attempting to final tighten the construct.This was removed and discarded, and a replacement implant used.No impact to the patient.There was a 5 minute delay in surgery.This report is for one single-inner setscrew.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint #:(b)(4).Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Part: 179702000s; lot: 331540.Manufacturing site: (b)(4).Release to warehouse date: 19.Jan.2022.No non-conformances /manufacturing irregularities related to the malfunction were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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 ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15077659
• MDR Text Key: 304544371
• Report Number: 1526439-2022-01262
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265063
• UDI-Public: (01)10705034265063
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2022

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: 179702000S
• Device Catalogue Number: 179702000S
• Device Lot Number: 331540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: X25 FINAL TIGHTENER; X25 FINAL TIGHTENER