MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE A4; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 189401404

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: kwp;kwq;mnh;mni;osh.A product investigation was conducted.Visual inspection: sfx,5.5,ti, med, size a4 was received at us cq.Upon visual inspection at cq, it is observed that the male cross connector body got stuck in the main assembly.X20 rounded set screw got jammed and it¿s head part got stripped.The rest of the surface of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Dimensional inspection: the dimensional inspection of the received device was performed at cq.The diameter of the shaft of the male cross connector body was measured and is within specifications as per the relevant drawing.Functional testing: functional testing cannot be performed at cq due to the jammed condition of the components of the device.Documentation/ specification review: the relevant drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is confirmed as the male cross connector body and x20 rounded screw got stuck in the main assembly.While a definitive root cause could not be determined for the jammed components, it is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 device history record (dhr) review was conducted: a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.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 the one (1) of the sfx crosslink implant a4 had problems with final tightening.Most likely implant cross-threaded.It could not be final tighten even with a different driver shaft.There was no issue with driver shaft.There was surgical delay of one (1) minute.A different implant with same product code was used to complete the procedure.Procedure was successfully completed.During manufacturer's investigation of the device on december 17, 2019, it is observed that the male cross connector body got stuck in the main assembly.X20 rounded set screw got jammed and it¿s head part got stripped.Concomitant device reported: unknown driver shaft (part#: unknown, lot#: unknown, quantity: unknown).This is report 1 of 1 for (b)(4).

• Brand Name: SFX,5.5,TI, MED, SIZE A4
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9571686
• MDR Text Key: 177865196
• Report Number: 1526439-2020-00335
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034168111
• UDI-Public: (01)10705034168111
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189401404
• Device Catalogue Number: 189401404
• Device Lot Number: OM10092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1