MAUDE Adverse Event Report: SYNTHES MEZZOVICO; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Unknown when the nerve damage occurred, but was sometime between procedure on (b)(6) 2016 and a couple of days later when the patient experienced numbness ((b)(6) 2016).510k: this report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Part is either part 04.005.412s, lot 9795591 (4.0mm ti locking screw w/t25 stardrive 22mm f/im nails-ster, udi: (b)(4) or part 04.005.410s, lot 9049130 (4.0mm ti locking screw w/t25 stardrive 20mm f/im nails-ster, udi: (b)(4), but it is unknown device is the complained screw.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A device history record review was completed for both potential part/lot combinations: manufacturing location: (b)(4).Part 04.005.412s, lot: 9795591: manufacturing date: january 15, 2016.Expiry date: january 01, 2026.Article was sterilized by supplier (b)(4) with lot number 9795591.Non sterile article 04.005.412 was manufactured with lot number 9786769.Part 04.005.410s, lot 9049130: manufacturing date: july 09, 2014.Expiry date: june 01, 2024.Article was sterilized by supplier (b)(4).Non sterile article 04.005.410 was manufactured with lot number 8975521.No deviation was found in the device history record review.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 europe reports an event in (b)(6) as follows: it was reported the patient had a multilock nail implanted for proximal humeral diaphyseal fracture procedure on (b)(6) 2016.Within a couple of days after the procedure, the patient claimed that she could not move her arm.The surgeon suspected the implanted screw might be causing the numbness.A revision procedure occurred on (b)(6) 2016.During that procedure, the surgeon confirmed the damage of the radial nerve where the most distal screw was implanted.He explanted the screw, sutured the damaged nerve and completed the procedure successfully.With the x-rays taken at the revision procedure, it was confirmed that the nail was inserted from the slight external-rotation position to the forward direction.The patient is reportedly doing well.This report is for an unknown screw.This is report 2 of 2 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6139071
• MDR Text Key: 61246679
• Report Number: 1000562954-2016-10220
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR