MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH TI LUMBAR EXTENSION SIZE 13/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.254

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Event date reported as (b)(6) 2017.It is unknown if this is the date the device broken or the date it was discovered broken.Unknown.Unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 the plate broke at the first hole.This is now the third plate break, at the same position in the same patient.No information about patient status.See also complaint (b)(4).This complaint involves 1 part.

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

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.

Manufacturer Narrative

Product investigation was performed.The returned lumbar extension rod is a component of the vertical expandable prosthetic titanium rib (veptr) system instrument and implant set (146.995).The veptr mechanically stabilizes and distracts the thorax, correcting thoracic deformities and providing improvement in volume of respiration and lung growth in infantile and juvenile patients diagnosed with or at risk of developing thoracic insufficiency syndrome per relevant technique guide.The lumbar extension is utilized for rib-to-lumbar lamina, rib-to-lumbar or rib-to-ilium constructs and is connected to a rib sleeve by an inferior distraction lock.The returned lumbar extension rod was examined and the complaint condition was able to be confirmed as the rod is broken in two locations.At the first hole and also on the solid cylindrical portion of the rod approximately 27mm (calipers ca592) from the transition of rod geometries.The material surface at the fracture sites appear homogeneous when viewed under 5x magnification.There is a portion of the rod that is missing/was not returned.The remainder of the device shows wear consistent with implantation and removal.No definitive root cause was able to be determined with the provided information.Because it was reported that this is now the third rod to break at the same position in the same patient, it is most likely that the rod size and/or construct is not adequate for the patient needs or that patient non-compliance has possibly occurred.Similarly, a material check was not performed at cq as there is no indication that the material would have contributed to this complaint.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.A review of the device history records was unable to be performed since the lot number was unknown.The portion of the plate with the lot# was a portion that broke off and was not returned.The only remaining etches on the returned part are "13 synthes logo and 497".Therefore, with the "13" etch before the synthes logo etch, it can be determined that the returned rod is actually part# 497.254, rather than the reported part# 497.252 by review of tabulated product drawing 497_131 current revision h.As a result, the part# in this complaint file was updated on 26-feb-2018 from 497.252 to 497.254 to account for the returned device that is broken.Tabulated product drawing for the family of long titanium lumbar extensions rods was reviewed during this investigation.The design, materials and finishing processes were found to be appropriate for the intended use of this device.For the returned device, the diameter of the cylindrical portion of the rod near location of breakage measured at cq and is within specification per tabulated product drawing.For the returned device, the height of the "t" shaped portion of the rod near location of breakage measured at cq and it is within specification per tabulated product drawing with reference to general tolerances for design and machining work instruction.For the returned device, the major width of the "t" shaped portion of the rod near location of breakage measured at cq and is within specification per tabulated product drawing.For the returned device, the minor width of the "t" shaped portion of the rod near location of breakage measured at cq and is within specification per tabulated product drawing with reference to general tolerances for design and machining work instruction.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

Manufacturer Narrative

A device history record (dhr) review was performed on part number: 497.254, lot number: h193627: manufacturing site: (b)94), supplier dhr: n/a, release to warehouse date: 04-oct-2016: no non- conformance reports (ncrs) were generated during production.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.Corrected data: physical manufacturer.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 LUMBAR EXTENSION SIZE 13/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7154235
• MDR Text Key: 96034651
• Report Number: 8030965-2017-51008
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747623
• UDI-Public: (01)07611819747623(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.254
• Device Lot Number: H193627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR