MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Compatibility Problem (2960)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4-510k: this report is for an unknown screws-spine/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H6: without a lot number the device history records review could not be completed.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.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 depuy synthes reports an event in germany as follows: it was reported that on (b)(6) 2023 during a revision of an unknown matrix degen lumbal spine construct, intraoperatively two depuy spine instrument twisted and it was not possible to open the screws´ closing caps.Surgeon therefore had to cut through the rods with the high-speed milling machine and use the 'helicopter technique' to unscrew the screws including the cap and rod.This led to metal debris/chips in the patient.The surgery was completed and the patient is doing well.This report is for an unk - screws: spine-us this is report 3 of 4 for complaint (b)(4).

• Brand Name: UNK - SCREWS: SPINE-US
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17663197
• MDR Text Key: 322419777
• Report Number: 8030965-2023-11033
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SPINE; UNK - GUIDES/SLEEVES/AIMING: SPINE; UNK - RODS; UNK - RODS: SPINE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: SPINE-US
• Patient Age: 71 YR
• Patient Sex: Female