MAUDE Adverse Event Report: SYNTHES BRANDYWINE SMALL TI RIB HOOK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.002

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event: unknown.This report is for an unknown veptr rib hook/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).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

Device report from synthes (b)(4) reported that a patient was originally implanted with vertical expandable prosthetic titanium rib ii (veptr ii) on an unknown date.Postoperative x-ray taken on an unknown date revealed that rib hook had been migrated from the rib.On (b)(6) 2016 the vertical expandable prosthetic titanium rib ii (veptr ii) revision surgery performed as the part of the planned treatment and also due to previous rib hook had migrated from the rib.Patient was implanted with four (4) new rods, three (3) new rib hooks, three (3) new rib hook caps and five (5) new distraction locking caps.Surgery was completed successfully with no other medical intervention required.Patient status reported as stable after the surgery.Concomitant device reported as: veptr rods distal and proximal (part unknown, lot unknown, quantity 4), rib hooks (part unknown, lot unknown, quantity 2), rib caps (part unknown, lot unknown, quantity 3), distraction locking caps (part unknown, lot unknown, quantity 3).There were several intra-operative issues which caused 45 minutes delay during the procedure; these are captured in linked (b)(4).This report is for an unknown veptr rib hook.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Received concomitant devices part number and lot number of one (1) of the three (3) rib caps initially reported as unknown.Updated part number and lot number of distraction locking caps.Device history record (dhr) review was completed for part # 04.641.002, lot # 6123429, manufacturing plant: (b)(4), manufacturing date: apr 13, 2009.Part # 04.641.002 is an assembly made of part # 04.641.002.1 (small rib hook body) lot # 6001794, part # 04.641.001.2 (barrel) lot# 6001742, and part # 04.641.001.3(nut) lot # 6001736.Dhr for all assembly components were reviewed.Dhr review for part # 04.641.002.1 (small rib hook body), lot # 6001794 manufactured at supplier (b)(4) on feb 27, 2009.No non conformance reports (ncr) generated that were relevant to the complaint condition of postoperative migration.Dhr for raw materials used to manufacture this lot were reviewed as part # 24019, type tialnbfi120.00x18.00, lot # 5881755, quantity (b)(4).Received from supplier (b)(4) on oct 20, 2008.Dhr reviewed, did not contain any non conformance reports or anomalies.Part # 21048, type tialnbri3.23, lot#3925992, quantity (b)(4).Received from supplier (b)(4) on apr 07,1999.Dhr reviewed, did not contain any non conformance report or anomalies.Dhr records for the raw material lot further indicate that the raw material underwent all required inspection and test requirements with no nonconformities reported.Dhr review for part # 04.641.001.2 (barrel), lot # 6001742 manufactured at supplier (b)(4) on mar 13, 2009.No non conformance reports (non conformance report) generated that were relevant to the complaint condition of postoperative migration.Dhr for raw material used to manufacture this lot was reviewed as part #21039, type tialnbri9.50, lot # 5124494, quantity (b)(4).Received from supplier (b)(4) on dec 21,2005.Dhr reviewed, did not contain any non conformance report or anomalies.Dhr records for the raw material lot further indicate that the raw material underwent all required inspection and test requirements with no nonconformities reported.Dhr review for part # 04.641.001.3 (nut), lot # 6001736 manufactured at supplier (b)(4) on dec 05, 2008.No non conformance reports (non conformance report) generated that were relevant to the complaint condition.Dhr for raw material used to manufacture this lot was reviewed as part #21039, type tialnbri9.50, lot # 5124494, quantity (b)(4).Received from supplier (b)(4) on dec 21, 2005.Dhr reviewed, did not contain any non conformance report or anomalies.Dhr records for the raw material lot further indicate that the raw material underwent all required inspection and test requirements with no nonconformities reported.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 diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant medical products: small ti rib hook cap (part # 04.641.008, lot # 6963216, quantity 1); rib hook caps (part unknown, lot unknown, quantity 2); distraction locking caps (part # 497.125, lot #s 6409102, 7535699, 9832340 quantity 3).

Manufacturer Narrative

After evaluation of the returned devices by the manufacturer it was determined that previously reported concomitant device small ti rib hook cap (part # 04.641.008, lot # 6963216, quantity 1) should have its own report and is no longer considered concomitant.A product investigation was completed: one (1) small titanium rib hook (part 04.641.002, lot 6123429, manufacture date april 13, 2009) and one (1) small ti rib hook cap (part 04.641.008, lot 6963216, manufacture date june 20, 2012) were returned with a complaint stating the rib hook migrated from the rib postoperatively.The devices were returned joined together by a distraction lock (497.125, lot 9832340).The devices exhibited scratches and discoloration indicative of post-manufacturing damage due to implantation/explantation.Since the devices were returned assembled without any significant damage outside of normal use, it is unlikely that the migration was as a direct result of a malfunction of the devices.It is also uncertain how long the device was implanted.The complaint of migration could not be confirmed with the given information.Although a definitive root cause could not be determined, stresses imposed on the device due to patient activity, patient growth, and/or improper tightening during implantation.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.Four (4) ti distraction locks (part 497.125; lots 9832340, 6409102, 7535699, 7004950) were returned as concomitant devices without an alleged complaint condition.Upon visual inspection, there is no evidence that these devices contributed to the complaint condition.Additionally, lot 9832340 that was returned assembled to the complaint devices is considered concomitant as its function is to hold the rib hook and the cap together and would not directly contribute to the complaint condition of malfunction.The relevant product drawings were reviewed during the investigation.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.No non-conformance reports 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.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

After evaluation of the returned devices by the manufacturer it was determined that previously reported concomitant device small ti rib hook cap (part # 04.641.008, lot # 6963216, quantity 1) should have its own report and is no longer considered concomitant.This is report 1 of 2 for (b)(4).

• Brand Name: SMALL TI RIB HOOK
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5956497
• MDR Text Key: 54935482
• Report Number: 2520274-2016-14552
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.002
• Device Lot Number: 6123429
• Other Device ID Number: (01)10705034749839(10)6123429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FOUR (4) UNKNOWN VEPTR RODS; THREE (3) UNKNOWN DISTRACTION LOCKING CAPS; THREE (3) UNKNOWN RIB CAPS; TWO (2) UNKNOWN RIB HOOKS
• Patient Outcome(s): Required Intervention