MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR KNOB; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.004

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received (b)(6).Device history records was conducted.The report indicates that the manufacturing location: (b)(4), 03.812.004/ lot# 8459795, manufacturing date: 14.Jun.2013.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 during a spinal fusion from t10 to the ilium, the following events occurred.While the surgeon was working at an unknown lumbar level, the tip of a t-pal trial spacers broke off into the t-pal spacer applicator knob.This event occurred twice.The tip of a t-pal spacer applicator inner shaft also broke off in a t-pal spacer applicator knob.Another part was immediately available for use.There was a 10 minute surgical delay related to the t-pal issues.During initial insertion of a screw at an unknown lumbar level, the tip of a holding sleeve broke off into the screw.The fragment tip was not retrieved and remained implanted in the patient.There was a 2 minute surgical delay related to the screwdriver sleeve issue.The surgery was completed successfully and no further patient harm was reported.The patient outcome was reported stable.No additional information will be available.This report is 1 of 7 of (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned applicator knobs (03.812.004 x 5) were examined and in three instances were found to have retained broken trial or applicator inner shaft proximal coupling heads.The knobs were able to be tested with a returned good trial (03.812.310 lot 9610063) and in each instance were found to function as intended.As the instruments functioned as intended and no visual defects were identifiable, no further investigation will be performed on the returned applicator knobs or the returned good trial.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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

This is report 2 of 10 for (b)(4).

Manufacturer Narrative

Additional narrative: subject device has been received and an investigation summary was performed.The investigation of the complaint articles has shown that: the tip of two t-pal trial spacers broke off into the t-pal spacer applicator knob resulting in a 10 minute surgical delay.The tip of a holding sleeve broke off into the screw resulting in a two minute surgical delay; the fragment was not retrieved and remained implanted in the patient.The surgery was completed successfully and no further patient harm was reported.The patient outcome was reported stable.No additional information will be available.The returned instruments were examined and the complaint condition was able to be confirmed as two t-pal trials (03.812.310 lots 8615791 and 9505116) were found to have broken proximal couplings and the matrix holding sleeve (03.632.036 lot 6512081) had a broken threaded tip.Additionally five applicator knobs (03.812.004 lots 8706081, 3438176, 8459795, 8918795 and 9700357) were returned, three of which retained broken proximal couplings from t-pal trial spacers or inner shafts.The knobs were tested and found to function as intended.Finally a third trial (03.812.310 lot 9610063) was returned intact and without identifiable defect or deficiency.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.

• Brand Name: T-PAL SPACER APPLICATOR KNOB
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5378583
• MDR Text Key: 36343433
• Report Number: 3003875359-2016-10034
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151276
• 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: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Device Lot Number: 8459795
• Other Device ID Number: (01)10705034727806(10)8459795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1