MAUDE Adverse Event Report: SYNTHES SALZBURG 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.017.225S

Device Problems Break (1069); Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: unknown when debris was generated.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(6).This determination will be reported as a serious injury/ malfunction to be cautious since there is an identified product malfunction; it is unknown when the metal debris was generated and the reason for the revision device history records review was conducted.The report indicates that the: 04.017.225s / 5930232 manufacturing location: (b)(4), manufacturing date: 14th august 2014, expiry date: 1st august 2019, article was sterilized by supplier (b)(4).No deviation or any ncrs were marked in this document.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 on an event in (b)(6) as follows: it was reported that the initial operation was performed with multiloc hn ø7 le cann l225 tan on (b)(6) 2015.The surgeon took out the nail in the revision on (b)(6) 2016.In the end of the revision, he pulled out the nail and found two pieces like metal remnants on the nail.There was a 5 minute surgical prolongation.No other medical intervention required, procedure successfully completed.This complaint involves 1 part.Concomitant devices: 1x 04.019.028s / 8776624 (multiloc screw ø4.5 l28 tan); 1x 04.019.032s/ 8345099 (multiloc¿ screw ø 4.5mm, l 32mm); 1x 04.005.414s / 9158210 (lockscr ø4 l24 f/nails tan dblue); 1x 04.019.000s / 5928484 (multiloc end cap f/multiloc hn/phn exten); 1x 03.019.007 / unk (connecscr cann f/multiloc hum nail syst); 1x 03.019.024 / unk (extractscr f/multiloc hum nail syst); 1x 03.019.028 / unk (combined hammer 360g).This report is 1 of 1 for (b)(4).

• Brand Name: 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5973794
• MDR Text Key: 55486080
• Report Number: 3009417901-2016-10036
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 04.017.225S
• Device Lot Number: 5930232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X 03.019.007, UNK CONNECSCR CANN F/MULTILOC HUM; 1X 03.019.024 / UNK EXTRACTSCR F/MULTILOC HUM NAI; 1X 03.019.028 / UNK (COMBINED HAMMER 360G); 1X 04.005.414S, LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; 1X 04.019.000S, MULTILOC END CAP F/MULTILOC HN/PH; 1X 04.019.028, 8776624 MULTILOC SCREW Ø4.5 L28 TAN; 1X 04.019.032S,MULTILOC¿ SCREW Ø 4.5MM, L 32MM
• Patient Outcome(s): Required Intervention