MAUDE Adverse Event Report: SYNTHES MEZZOVICO 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.003.028

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

Due to intraoperative issues, device was not implanted or explanted.Device is expected for return but has not been received yet.(b)(4).Manufacturing site: (b)(4).Manufacturing date: mar 07, 2016.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device used for treatment, not for diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2016, patient underwent an intramedullary nailing procedure.It was reported that during the procedure, a reamer head would not go on the flexible reamer shaft.The surgeon did have another reamer shaft on hand for use.In the same procedure a screw would not advance while putting it through the nail.The screw was reported as not going in or coming out.It caused a 30 minute delay in surgery to pull the screw out.Another screw was obtained, which also got stuck.This time a mallet was used to hammer the screw in the nail to get it past the threading.This caused the surgeon to put a larger incision in the patient.The surgery was completed successfully and patient was reported as being stable.Concomitant devices reported: reamer head (part# unknown, lot# unknown, quantity 1).This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Additional patient id: (b)(6).Exact patient weight is (b)(6).Product investigation was completed.Part # 04.003.028, lot # 9862450 was received.This device is heavily scratched and marred.It appears that the device was contacting another metallic object that prevented its proper insertion.This complaint condition could not be confirmed since only the screw was received for investigation.Drawing for the device was reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The complaint condition could not be confirmed.Device 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

Date received by mfr: sep 22, 2016.In the follow up medwatch # (b)(4), date received by manufacturer should have been sep 22, 2016.Incorrect date entered in error.Device 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: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5921113
• MDR Text Key: 53701889
• Report Number: 1000562954-2016-10179
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.003.028
• Device Lot Number: 9862450
• Other Device ID Number: (01)10886982081599(10)9862450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2016; 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN REAMER HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 82