MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION SIZE 8/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.078

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

Patient weight not provided by reporter.Event occurred during a planned revision surgery to lengthen rod, however device broke intra-operatively making the rod unable to be reinserted.(b)(4).Without a valid 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.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

It was reported that during a planned veptr ii lengthening procedure, surgeon attempted to bend the rod for more kyphosis and the rod broke into two pieces.The broken rod was removed and replaced with a new rod.Two (2) additional set screws were also added.No fragments remain in the patient.It is also reported surgeon removed a pangea pedicle screw and lateral connector at an unknown level because the screw had loosened in the pedicle.The screw and connector were not replaced.Procedure was extended approximately 20 minutes and a new distal incision was made at the connector location.Procedure was completed successfully with no further harm to patient.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing date: december 11, 2013.Lot 7543992 did not contain any non-conformance reports (ncr) or any anomalies.Total lot pieces were (b)(4), but (b)(4) were accepted/conforming.One (1) piece was scrapped.The following lot number for component 24019 was reviewed: 6962934.Part 24019 / lot 6962934 did not contain any ncrs or any anomalies.Total lot (b)(4) were accepted/conforming.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.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

A product investigation was completed: the returned device was evaluated and the complaint condition was able to be confirmed as the distal extension was returned broken into two segments.Based on the compliant description it is likely that the failure occurred as a result of the application of excessive forces while bending.The returned distal extension (part 04.641.078 lot 7543992) was examined and the complaint condition was able to be confirmed as the instrument was received broken approximately 88mm from the proximal end of the implant.Additionally approximately 70mm has been cut off of the distal end of the implant; the cut segment was not returned.Both returned pieces show witness marks consistent with contouring and cutting to length (worn anodization, scratches, and gouges).Per the technique guide, the implant is a component of the veptr (vertical expandable prosthetic titanium rib) system.Relevant drawings for the returned implant were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument¿s lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.Based on the compliant description it is likely that the failure occurred as a result of the application of excessive forces while bending.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.

• Brand Name: TI DISTAL EXTENSION SIZE 8/500MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5052904
• MDR Text Key: 24894434
• Report Number: 2520274-2015-15654
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.078
• Device Lot Number: 7543992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR