MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/34MM-STER; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 412.113S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date is not known.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) reports an event in (b)(6) as follows: it was reported patient was implanted on unknown date with a locking compression plate (lcp) medial proximal tibia plate and unknown quantity of screws.Patient was returned to surgery on (b)(6) 2017 for a planned removal of the implants.During the removal procedure, it was noted that the 3.5mm locking screw that had been fixed on the proximal side of the plate had broken around the screw head.Surgeon noted the screw broke post-operatively and not during removal.It was further noted that some fragments from the broken screw may have been left in the patient.Surgery was completed successfully, patient bone is reported as healed and patient status reported as good.Concomitant devices reported: lcp medial proximal tibia plate (part 439.956s, lot number unknown, quantity 1) this report is for one (1) 3.5mm titanium locking screw this is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/34MM-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6755140
• MDR Text Key: 81507954
• Report Number: 9612488-2017-10375
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.113S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 75